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For Fragment-Specific Fracture Fixation Using the Variable Angle LCP ® Two-Column Volar Distal Radius Plate 2.4 With Variable Angle Locking Technology Sterile Distal Radius Kit Surgical Technique

Transcript of Surgical Techniquesynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · Sterile...

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For Fragment-Specific Fracture Fixation Using the Variable Angle LCP® Two-Column Volar Distal Radius Plate 2.4 With Variable Angle Locking Technology

Sterile Distal Radius KitSurgical Technique

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Image intensifier control

WarningThis description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

MRI Information

Bibliography

Indications 3

Sterile Kit Variations and Added Instruments 4

Distal Radius Sterile Kit Key Steps 6

Sterile Tube Packaging 7

AO Principles 8

Clinical Cases 9

Approach 10

Implantation Steps 11

Postoperative Treatment and Implant Removal 21

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2 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 3

Indications

Variable Angle LCP® Two-Column Volar Distal Radius Plates 2.4 are indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

Indications

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4 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Sterile Kit Variations and Added Instruments

Variable Angle LCP® Volar and Dorsal Distal Radius Plates 2.4.

Sterile Instruments and Implants for multi-fragment fracture fixation with variable angle locking technology.

Core sterile kits Core sterile kits contain both the implants and instruments to perform one distal radius surgery with a 3-shaft hole VA-LCP Two-Column Distal Radius Plate 2.4. All implants are available in both Stainless Steel and Titanium.

Extra screws are provided single-packed in sterile packaging.

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 5

Sterile Kit Variations and Added Instruments

Sterile instrument kits with individually packed sterile plates and screwsInstrument kits are part of a modular system with individually packed sterile plates and screws. They contain only the instruments needed to perform one distal radius surgery with the following DePuy Synthes Variable Angle radius plates:

VA-LCP Two-Column Distal Radius Plates 2.4 VA-LCP Two-Column Distal Radius Plates, 2.4/2.7, Extra-Long VA-LCP Extra-articular Distal Radius Plates 2.4 VA-LCP Dorsal Distal Radius Plates 2.4

Plates and screws are available single-packed in sterile packaging.

Trial implantsIn addition, sterile trial implants are available separately to determine the correct plate length and width of VA-LCP Two-Column Distal Radius Plates.

Implant removal screwdriverThe single-use T8 screwdriver is designed to facilitate implant removal without the need for a sterile instrument kit. Note that the screwdriver tip is non-retaining to facilitate maximum torque transmission.

Note: All implants and instruments of the Sterile Distal Radius Kit are single use. Do not resterilize. Dispose of all unused items after surgery.

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6 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Distal Radius Sterile Kit Key Steps

Note: Please refer to the corresponding IFU (www.depuysynthes.com/ifu) and this surgical technique for full usage information.

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 7

Sterile Tube Packaging

The amount and lengths of screws contained in the Distal Radius Single Use Kit has been identified both scientifically to fit various anatomies and through historical sales data. For most cases, the kit will contain screws of sufficient length. It is recommended to measure each hole’s depth to determine the correct screw length based on the current recommendation of the literature.3,10

Extra screws that are not contained in the kit are available individually packed in sterile tubes.

Leading the Way to Sterile ImplantsThe Sterile Tube concept consists of a solution that uses 2 tubes where one fits into the other to allow a streamlined and secure transfer of sterile implants into the sterile field.

Follow the following steps to access a sterile screw:

Step 1: Tear the pull-strip open to remove the sleeve.

Step 2: Open the outer tube by unscrewing the outer cap from the outer tube. Do not touch the inner tube to maintain sterility.

Step 3:Circulating Nurse (non-sterile field): Hold the outer cap and point the inner tube towards the sterile field.Scrub Nurse (sterile field): Remove the inner tube by pulling and if necessary slightly twisting the inner tube back and forth to release it from the outer cap. When twisting the tube, hold on to the tube and not the cap.

Step 4: Open the inner tube by unscrewing the inner cap from the inner tube and remove the holder with the screw.

Step 5: Engage the screwdriver in the screw recess and if necessary secure with finger. Remove the screw from the holder by tilting it out of the holder/tilting the holder away at the opening.

sterile field

sterile field

sterile field

non-sterile field

non-sterile field

non-sterile field

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8 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

AO Principles

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4_Priciples_03.pdf 1 05.07.12 12:08

4 DePuy Synthes Expert Lateral Femoral Nail Surgical Technique

AO PRINCIPLES

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation1, 2.

1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991.

2 Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Stable fixationFracture fixation providing abso-lute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.1,2

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Stable fixationFracture fixation providing absolute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.

1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer-Verlag; 1991.

2. Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart New York: Thieme; 2007.

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 9

Clinical Cases

Case 124-year-old male with AO 23C2.1 fracture, fall from scaffold

Case 277-year-old female with AO 23C1 fracture, fall

Preoperative, AP view

Preoperative, AP view

Preoperative, lateral view

Preoperative, lateral view

Postoperative, AP view

Postoperative, AP view

Postoperative, lateral view

Postoperative, lateral view

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11 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Approach

Make a longitudinal incision slightly radial to the flexor carpi radialis tendon (FCR). Dissect between the FCR and the radial artery, exposing the pronator quadratus. Detach the pronator quadratus from the lateral border of the radius and elevate it toward the ulna.

Note: Leave the volar wrist capsule intact to avoid devascularization of the fracture fragments and destabilization of the volar wrist ligaments.

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 11

Implantation Steps

1. Select implant

Instrument

03.111.120S Trial Implants for VA-LCP Two-Column Distal Radius Plate 2.4, sterile

Trial implantsDouble-sided sterile trial implants may be used to identify the desired plate size prior to opening a distal radius sterile kit. Trial implants with 3 shaft holes are available for VA-LCP Two-Column Volar Distal Radius Plates 2.4.

Trial implants are marked with Left (L) and Right (R) as well as the corresponding plate type (narrow, standard, wide).

Select the correct distal radius sterile kit according to the trial implant matching the bone and fracture pattern with respect to side (left and right, facing up) and size (narrow, standard, wide).

Precaution: Ensure proper plate selection by verifying the L (left) and R (right) etching on the trial implant. The trial implant’s distal lip is slightly lower on the radial side.

Note: Excessive and repetitive bending of the trial implants should be avoided.

Trial implant choices, for VA-LCP Two-Column Volar Distal Radius Plates 2.4 (narrow, standard, wide head sizes).

Trial implants are double-sided (L and R version).

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12 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Implantation Steps

2. Reduce fracture and position plate

Instrument

292.120 Kirschner Wires Ø 1.25 mm, with trocar tip

Reduce the fracture The reduction method will be fracture-specific.

Position plateApply the plate to fit the volar surface.

The order of screw insertion and the use of K-wires may vary depending on the fracture pattern and reduction technique.

If necessary, use 1.25 mm K-wires inserted through the desired Kirschner-wire hole to temporarily fix the plate distally. The distal K-wire holes of the plate are designed to indicate the nominal screw trajectory angle of the screw hole medial to the respective K-wire hole.

Perform several radiographic views of the distal radius to ensure alignment, plate placement, and fracture reduction.

Additional options for preliminary Kirschner wire fixation

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 13

Implantation Steps

3. Insertion of proximal screws

Instruments

03.111.113 1.8 mm Drill Bit, quick coupling

03.111.112 1.8 mm VA/Cortex Drill Guide

03.111.111 1.8 mm Coaxial Drill Guide

03.111.114 2.4/2.7 mm Depth Gauge

03.111.115 0.8 Nm Torque-limiting Screwdriver, T8

Determine where 2.4 mm locking screws and 2.4 mm cortex screws will be used in the plate. The order of screw insertion in the shaft and metaphysis may vary depending on the fracture pattern and reduction technique.

Verify plate and distal screw location with a drill bit or K-wires before inserting multiple screws.

Cortex Screws

Drill using VA/Cortex Drill Guide Beginning with the center of the elongated hole in the shaft of the plate, drill with the 1.8 mm drill bit using the 1.8 mm VA/Cortex drill guide.

Note: The 1.8 mm VA/Cortex drill guide should be fully inserted in cortex or VA plate holes. Moderate pressure should be applied to keep guide inserted in plate hole when drilling.

Precaution: Excessive force should be avoided while drilling to avoid bending or damaging the drill.

03.111.113

03.111.112

03.111.111

03.111.114

03.111.115

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14 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Implantation Steps

Insertion of proximal screws (continued)

Determine screw length of cortex screws Engage the hook of the 2.4/2.7 mm depth gauge at the opposite cortex and shift the sleeve down into the hole (1). Take the reading from the edge of the sleeve (2) and select a screw length corresponding to the reading.

Insert cortex (non-locking) screwInsert an appropriate length 2.4 mm cortex screw in the elongated hole in the plate shaft. Adjust the plate position if necessary and tighten the screw with the screwdriver.

Depending on fixation requirements, additional cortex screws may be inserted into remaining unthreaded shaft holes following the steps above.

Note: If dense bone is preventing screw insertion by engaging the torque-limiting function of the screwdriver before the screw head is seated, the torque-limiting stop should be attached to the torque-limiting screwdriver. Then carefully tighten the screw paying attention not to overtighten it. For assembly of the torque-limiting stop refer to chapter “Torque-limiting Stop for Dense Bone”.

1

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 15

Implantation Steps

Insertion of proximal screws (continued)

Locking Shaft Screws Drill using the Coaxial Drill GuideFor locking screws, carefully insert the 1.8 mm coaxial drill guide into the threaded portion of the shaft hole until it is seated in the desired locking hole. Drill with the 1.8 mm drill bit.

Note: The 1.8 mm coaxial drill guide should be inserted in-axis to the plate hole and tightened until held in plate. Excessive torque should be avoided.

Precaution: Excessive force should be avoided while drilling to avoid bending or damaging the drill.

Determine screw length Use the 2.4/2.7 mm depth gauge to determine the screw length.Take the reading from the edge of the sleeve (see arrow).

Insert a locking screwUsing the T8 torque-limiting screwdriver, insert the screw perpendicular to the plate surface until the screw head is seated.

Note: If dense bone is preventing screw insertion by engaging the torque-limiting function of the screwdriver before the screw head is seated, the torque-limiting stop should be attached to the torque-limiting screwdriver. Then carefully tighten the screw paying attention not to overtighten it. For assembly of the torque-limiting stop refer to chapter “Torque-limiting Stop for Dense Bone”.

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16 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Implantation Steps

4. Insertion of distal screwsFor used instruments, please refer to page 13.

4a. Determine whether screws will be inserted at the pre-defined nominal angle (option 1) or at a variable angle (option 2).

Option 1: Pre-defined angle drillingTo follow the nominal trajectory of a locking hole, insert the 1.8 mm coaxial drill guide in-axis to the nominal angle of the plate hole. Drill with the 1.8 mm drill bit.

Precaution: Excessive force should be avoided while drilling to avoid bending or damaging the drill.

Option 2: Variable angle drillingUse the 1.8 mm VA/cortex drill guide. Fully seat it into the VA locking hole. Drill holes at the desired angle with the 1.8 mm drill bit. Moderate pressure should be applied to keep the guide inserted in the plate hole when drilling.

Precaution: To ensure that the screw is locked correctly, do not angle it in excess of +/– 15° from the nominal trajectory of the hole. Excessive force should be avoided while drilling to avoid bending or damaging the drill.

To achieve the desired angle, verify the drill bit angle under image intensifier control. If necessary, drill at a different angle and verify again under image intensifier control.

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 17

Implantation Steps

4b. Determine screw length

Use the 2.4/2.7 mm depth gauge to determine the screw length.

If the fracture type allows, choose a screw length shorter than measured to ensure the screw does not protrude from the dorsal cortex.3,10

4c. Insert VA locking screws

Using the T8 torque-limiting screwdriver, insert the screw in the direction of the previously drilled hole until the screw head is seated.

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18 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Implantation Steps

5. Ensure proper joint reconstructionEnsure proper joint reconstruction, screw placement and screw length using multiple radiographic views. Verify that the distal screws are not in the joint by using additional views such as a 10° dorsally tilted, 20° inclined lateral, 45° pronated oblique, and the dorsal tangential view.5,6

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 19

Implantation Steps

6. Final fixation of VA locking screws

Instruments

03.111.115 Torque-limiting Screwdriver, T8

03.111.116 Torque-limiting Stop Optional: intended to be used only in case of dense bone

Use the T8 torque-limiting screwdriver to perform the final locking step for VA locking screws.

Insert the screw until you hear a click.

The torque-limiting screwdriver prevents over-tightening and ensures that the VA locking screws are securely locked into the plate.

Note: For dense bone, visually inspect if the screw is appropriately threaded and seated after tightening with the torque-limiting screwdriver. If dense bone is preventing screw insertion, the torque-limiting stop should be attached to the torque-limiting screwdriver. Then carefully tighten the screw until the head is flush with the plate surface. For a detailed description of screw insertion and assembly of the torque-limiting stop refer to chapter “Torque-limiting Stop for Dense Bone”.

Precaution: Remove the torque-limiting stop from the screwdriver when not necessary to overcome dense bone.

03.111.115

03.111.116 (optional)

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21 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Implantation Steps

Torque-limiting Stop for Dense Bone (optional)

Instruments

03.111.115 Torque-limiting Screwdriver, T8

03.111.116 Torque-limiting Stop

Optional: intended to be used only in case of dense bone

Visually inspect if the screw is appropriately threaded and seated after tightening with the torque-limiting handle.

If dense bone is preventing screw insertion, the torque-limiting stop should be attached to the torque-limiting handle.

To attach the torque-limiting stop ensure that the triangles on both the torque-limiting stop and the handle are aligned. Rotation may be required for alignment.

Then carefully tighten so that the screw head is flush with the plate surface. Confirm final locking with the torque-limiting stop removed.

Precaution: Remove the torque-limiting stop from the screwdriver when not necessary to overcome dense bone.

03.111.115

03.111.116 (optional)

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 21

Postoperative Treatment and Implant Removal

Postoperative treatment Postoperative treatment with VA locking compression plates does not differ from conventional internal fixation procedures and is at the discretion of the clinician.

Implant removal

Instrument

03.111.117S Screwdriver, T8, non-retaining, sterile For implant removal

The screwdriver for implant removal is not designed for screw retention.

Before attempting screw removal clean all screw head recesses of tissue or ingrown/overgrown bone using a dental pick or other appropriate instrument.

To remove locking screws, first unlock all screws from the plate; then remove the screws completely from the bone.

The last screw removed should be a non-locking screw on the shaft. This prevents the plate from spinning when locking screws are removed.

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22 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Product Information

Sterile Implant and Instrument Kits with VA-LCP Two-Column Volar Distal Radius Plates

Stainless Steel*

Head size Head Shaft Length Left/ Part number (mm) holes holes (mm) Right

02.111.530KS narrow 19.5 6 3 51 R02.111.531KS narrow 19.5 6 3 51 L02.111.630KS standard 22 6 3 54 R02.111.631KS standard 22 6 3 54 L02.111.730KS wide 25.5 7 3 55 R02.111.731KS wide 25.5 7 3 55 L

Titanium**

Head size Head Shaft Length Left/ Part number (mm) holes holes (mm) Right

04.111.530KS narrow 19.5 6 3 51 R04.111.531KS narrow 19.5 6 3 51 L04.111.630KS standard 22 6 3 54 R04.111.631KS standard 22 6 3 54 L04.111.730KS wide 25.5 7 3 55 R04.111.731KS wide 25.5 7 3 55 L

Trial Implants for Two-Column Distal Radius Plates03.111.120S Trial Implants for VA-LCP Two-Column

Distal Radius Plates 2.4, sterile

03.111.121S Trial Implants for VA-LCP Two-Column Distal Radius Plates 2.4/2.7, Extra-Long, sterile

Implant Removal Screwdriver

03.111.117S Screwdriver, T8, non-retaining, sterile For implant removal

03.111.120S 03.111.121S

* Plates and screws are made from stainless steel (316L).** Plates are made from commercially pure titanium (TiCP), and screws are

made from titanium alloy (Ti-6Al-7Nb).

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 23

Product Information

Instrument-only Kit 03.111.100S VA-LCP Instrument Kit 2.4, sterile

Individually Packed Sterile PlatesAvailable for use with Instrument-only Kit

VA-LCP Two-Column Volar Distal Radius Plates 2.4, sterile

Narrow, width 19.5 mm

Head Shaft Length Left/ Stainless Steel Titanium holes holes (mm) Right

02.111.520S 04.111.520S 6 2 42 R02.111.521S 04.111.521S 6 2 42 L02.111.530S 04.111.530S 6 3 51 R02.111.531S 04.111.531S 6 3 51 L02.111.540S 04.111.540S 6 4 63 R02.111.541S 04.111.541S 6 4 63 L02.111.550S 04.111.550S 6 5 72 R02.111.551S 04.111.551S 6 5 72 L

Standard, width 22 mm

Head Shaft Length Left/ Stainless Steel Titanium holes holes (mm) Right

02.111.620S 04.111.620S 6 2 45 R02.111.621S 04.111.621S 6 2 45 L02.111.630S 04.111.630S 6 3 54 R02.111.631S 04.111.631S 6 3 54 L02.111.640S 04.111.640S 6 4 66 R02.111.641S 04.111.641S 6 4 66 L02.111.650S 04.111.650S 6 5 75 R02.111.651S 04.111.651S 6 5 75 L

Wide, width 25.5 mm

Head Shaft Length Left/ Stainless Steel Titanium holes Holes (mm) Right

02.111.720S 04.111.720S 7 2 47 R02.111.721S 04.111.721S 7 2 47 L02.111.730S 04.111.730S 7 3 55 R02.111.731S 04.111.731S 7 3 55 L02.111.740S 04.111.740S 7 4 68 R02.111.741S 04.111.741S 7 4 68 L02.111.750S 04.111.750S 7 5 77 R02.111.751S 04.111.751S 7 5 77 L

All plates are sterile packed.Images show selected right plates in both stainless steel (316L) and commercially pure titanium (TiCP) materials.

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24 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Product Information

VA-LCP Two-Column Volar Distal Radius Plates 2.4/2.7, Extra-Long, sterile

Head size Head Shaft Length Left/ Stainless Steel Titanium (mm) holes holes (mm) Right

02.111.570S 04.111.570S narrow 19.5 6 7 105 R02.111.571S 04.111.571S narrow 19.5 6 7 105 L02.111.670S 04.111.670S standard 22 6 7 109 R02.111.671S 04.111.671S standard 22 6 7 109 L02.111.770S 04.111.770S wide 25.5 7 7 110 R02.111.771S 04.111.771S wide 25.5 7 7 110 L02.111.680S 04.111.680S standard 22 6 10 145 R02.111.681S 04.111.681S standard 22 6 10 145 L02.111.690S 04.111.690S standard 22 6 13 186 R02.111.691S 04.111.691S standard 22 6 13 186 L

VA-LCP Extra-Articular Volar Distal Radius Plates 2.4, sterile

Head Shaft Length Left/ Stainless Steel Titanium holes holes (mm) Right

02.110.201S 04.110.201S 5 3 48 R

02.110.203S 04.110.203S 5 3 48 L

02.110.202S 04.110.202S 5 5 66 R

02.110.204S 04.110.204S 5 5 66 L

02.110.205S 04.110.205S 4 3 45 R

02.110.207S 04.110.207S 4 3 45 L

02.110.206S 04.110.206S 4 5 65 R

02.110.208S 04.110.208S 4 5 65 L

All plates are sterile packed.Images show selected right plates in both stainless steel (316L) and commercially pure titanium (TiCP) materials.

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 25

Product Information

VA-LCP Dorsal Distal Radius Plates 2.4, sterile

Radial Column

• Shaft Length Stainless Steel Titanium holes (mm)

02.115.530S 04.115.530S 5 46

02.115.540S 04.115.540S 6 57

Intermediate Column, 2 head holes

Note: The plates for the right radius (0x.115.630 and 0x.115.640) are angled left and the plates for the left radius (0x.115.631 and 0x.115.641) are angled right.

•• Shaft Length Stainless Steel Titanium holes (mm) Angle

02.115.630S 04.115.630S 3 41 -90°

02.115.631S 04.115.631S 3 41 +90°

02.115.640S 04.115.640S 4 49 -90°

02.115.641S 04.115.641S 4 49 +90°

L-Plates, 2 head holes

•• Shaft Length Stainless Steel Titanium holes (mm) Angle

02.115.130S 04.115.130S 3 37 +90°

02.115.131S 04.115.131S 3 37 -90°

02.115.150S 04.115.150S 5 51 +90°

02.115.151S 04.115.151S 5 51 -90°

L-Plates, 3 head holes

• Shaft Length Stainless Steel Titanium holes (mm) Angle

02.115.230S 04.115.230S 3 37 +90°

02.115.231S 04.115.231S 3 37 -90°

02.115.250S 04.115.250S 5 51 +90°

02.115.251S 04.115.251S 5 51 -90°

All plates are sterile packed.Images show selected right plates in both stainless steel (316L) and commercially pure titanium (TiCP) materials.

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26 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

Product Information

L-Plates, oblique, 3 head holes

•• Shaft Length Stainless Steel Titanium holes (mm) Angle

02.115.430S 04.115.430S 3 41 +20°

02.115.431S 04.115.431S 3 41 -20°

02.115.450S 04.115.450S 5 55 +20°

02.115.451S 04.115.451S 5 55 -20°

T-Plates, 3 head holes

•• Shaft Length Stainless Steel Titanium holes (mm)

02.115.330S 04.115.330S 3 37

02.115.350S 04.115.350S 5 51

Note: This Surgical Technique does not include information necessary for selection and use of Variable Angle LCP Extra-Articular Volar Distal Radius Plates 2.4 and Variable Angle LCP Dorsal Distal Radius Plates 2.4. Please refer to the corresponding Surgical Technique for all necessary implant-specific information.

All plates are sterile packed.Images show selected right plates in both stainless steel (316L) and commercially pure titanium (TiCP) materials.

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 27

Product Information

Individually Packed Sterile Screws

Ordering Information

Variable Angle Locking Screws Ø 2.4 mm, with T8 StarDrive recess, tube sterile

Stainless Steel* Titanium* Length (mm)

02.210.108TS 04.210.108TS 8

02.210.110TS 04.210.110TS 10

02.210.112TS 04.210.112TS 12

02.210.114TS 04.210.114TS 14

02.210.116TS 04.210.116TS 16

02.210.118TS 04.210.118TS 18

02.210.120TS 04.210.120TS 20

02.210.122TS 04.210.122TS 22

02.210.124TS 04.210.124TS 24

02.210.126TS 04.210.126TS 26

02.210.128TS 04.210.128TS 28

02.210.130TS 04.210.130TS 30

Cortex Screws Ø 2.4 mm, with T8 StarDrive recess, tube sterile

Stainless Steel* Titanium* Length (mm)

201.758TS 401.758TS 8

201.760TS 401.760TS 10

201.762TS 401.762TS 12

201.764TS 401.764TS 14

201.766TS 401.766TS 16

201.768TS 401.768TS 18

201.770TS 401.770TS 20

201.772TS 401.772TS 22

201.774TS 401.774TS 24

201.776TS 401.776TS 26

201.778TS 401.778TS 28

201.780TS 401.780TS 30

* Stainless Steel (316L) Titanium Alloy (Ti-6AI-7Nb)

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28 DePuy Synthes Sterile Distal Radius Kit Surgical Technique

MRI Information

Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F2119-07Non-clinical testing of worst case scenario in a 3 T MRIsystem did not reveal any relevant torque or displacementof the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F2182-11aNon-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5°C with an average temperature rise of 6.6°C (1.5 T) and a peak temperature rise of 5.9°C (3 T) under MRI Conditions using RF Coils [whole body averaged specific absorption rate (SAR) of 2 W/kg for 6 minutes (1.5 T) and for 15 minutes (3 T)].

Precautions: The above mentioned test relies on non-clinical testing. The actual temperature rise in the patient will depend on a variety of factors beyond the specific absorption rate (SAR) and time of RF application. Thus, it is recommended to pay particular attention to the following points:– It is recommended to thoroughly monitor patients

undergoing MR scanning for perceived temperature and/or pain sensations.

– Patients with impaired thermo regulation or temperature sensation should be excluded from MR scanning procedures.

– Generally it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed SAR should be reduced as far as possible.

– Using the ventilation system may further contribute to reduce temperature increase in the body.

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Sterile Distal Radius Kit Surgical Technique DePuy Synthes 29

Bibliography

1. Brink PR, Rikli DA. Four-Corner Concept: CT-Based Assessment of Fracture Patterns in Distal Radius. J Wrist Surg. 2016;5:147-51.

2. Hart A, Collins M, Chhatwal D, Steffen T, Harvey EJ, Martineau PA. Can the use of variable-angle volar locking plates compensate for suboptimal plate positioning in unstable distal radius fractures? A biomechanical study. J Orthop Trauma. 2015;29:1-6.

3. Löw S, Herold D, Eingartner C. Standardized Palmar Plating of Dorsally Displaced Distal Radius Fractures. Tech Hand Up Extrem Surg. 2013;17:106-11.

4. Oppermann J, Wacker M, Stein G, Springorum HP, Neiss WF, Burkhart KJ, Eysel P, Dargel J. Anatomical fit of seven different palmar distal radius plates. Arch Orthop Trauma Surg. 2014;134:1483-9.

5. Ozer K, Wolf JM, Watkins B, Hak DJ. Comparison of 4 fluoroscopic views for dorsal cortex screw penetration after volar plating of the distal radius. J Hand Surg Am. 2012;37:963-7.

6. Pace A, Cresswell T. Use of articular wrist views to assess intra-articular screw penetration in surgical fixation of distal radius fractures. J Hand Surg Am. 2010;35:1015-8.

7. Rausch S, Klos K, Stephan H, Hoffmeier K, Gras F, Windolf M, Gueorguiev B, Hofmann GO, Mückley T. Evaluation of a polyaxial angle-stable volar plate in a distal radius C-fracture model--a biomechanical study. Injury. 2011;42:1248-52.

8. Rausch S, Schlonski O, Klos K, Gras F, Gueorguiev B, Hofmann GO, Mückley T. Volar versus dorsal latest-generation variable-angle locking plates for the fixation of AO type 23C 2.1 distal radius fractures: a biomechanical study in cadavers. Injury. 2013;44:523-6.

9. Stanbury SJ, Salo A, Elfar JC. Biomechanical analysis of a volar variable-angle locking plate: the effect of capturing a distal radial styloid fragment. J Hand Surg Am. 2012;37:2488-94.

10. Tarallo L, Mugnai R, Zambianchi F, Adani R, Catani F. Volar plate fixation for the treatment of distal radius fractures: analysis of adverse events. J Orthop Trauma. 2013;27:740-5.

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