Osteosynthesis Set - DMV · 2013. 10. 26. · The osteosynthesis set is designed for a operative...

$: Osteosynthesis Set - DMV · 2013. 10. 26. · The osteosynthesis set is designed for a operative fracture treatment, anatomical reconstruction and for the re-establishment of lost$
Operation Manual

Lockable screw and plate set with instruments for fracture treatment in veterinary medicine.

VeterinaryOsteosynthesis Set

ADVANCED LOCKING SYSTEM

Endorsements“�The� Pax� system� has� dramatically� increased� our�

surgical� options� for� repairing� complex� fractures.� Not�

only�does�it�allow�us�to�incorporate�all�the�advantages�

that�locking�plates�have�to�offer,�but�also,�the�ability�to�

angle�screws�and�still�maintain�locking�stability�is�very�

useful.�The�implant�and�instrumentation�sets�are�also�

thoughtfully�designed�for�easy�intraoperative�use.”

Matthew Barnhart, DVM, MS, DACVS MedVet, OH

“�The� advantages� of� a� locking� plate� coupled� with� the�

ability� for�screw�angulation�make� the�Pax�a�versatile�

implant� system.� With� indications� from� diaphyseal�

fractures� to� articular� fractures,� the� Pax� greatly�

enhances�the�armature�of�the�orthopedic�surgeon.”

Fred Pike, DVM, DACVS Veterinary Specialty Hospital, CA

“�We�have�found�the�Pax�system�to�be�quite�versatile.�

We�have�used� it� for�everything� from�simple� fractures�

to� bilateral� pancarpal� arthrodeses.� The� flexibility� of�

the�plate�makes� it�easy�to�contour,�the�multiple�sizes�

of� implants� make� the� system� useful� in� a� variety� of�

situations,� and� the� locking� system� is� quite� unique.�

The� greatest� thing� about� this� system� is� the� locking�

mechanism.�The�two�differences�in�this�locking�system�

that� are� most� useful� are� the� ability� to� place� screws�

at� almost� any� angle� and� the� fact� that� if� adjustments�

need�to�be�made�during�the�repair�the�screws�can�be�

loosened�and�will�relock�into�the�plate.�“

Christopher L. Horstman, DVM, MS, DACVS Las Vegas Veterinary Referral Center, NV

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3

Table of Contents

04 Introduction

05 System�Description

06 Operation�Technique

10 Clinical�Indications

12 Mechanical�Techniques

16 Ordering�Information

20 Plate�Sizing�Templates

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Introduction

The osteosynthesis set is designed for a

operative fracture treatment, anatomical

reconstruction and for the re-establishment of

lost functionality. The modern plate geometry

offers the veterinary surgeon a range of

application from the extremities to the spine.

An unknown biomechanical loading post-

operative of various animals poses a greater

risk of repostition. The poly-axial angularly-

stable screw plate locking system reduces the

risk of primary or secondary loss of reposition.

The plate and screws present a stable system

which provides the fundamental condition for

bone osteosynthesis. Because it is possible to

lock the plates without pressing them onto the

bone, similar to an internal fixator, this does

not impair the blood circulation.

The plates are equipped with bending zones

between the locking holes to aid the shaping

of the plates for the particular bones.

Veterinary Osteosynthesis: Lockable�screw�and�plate�set�with�instruments�for�fracture�treatment�in�veterinary�medicine.

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System DescriptionThe angularly-stable screw-plate locking system

offers a poly-axial insertion of the screws into

the plate at an angle of +/- 10°. The stability of

the fracture treatment is the result of the high

construct stiffness and is almost independent of

the bone quality, contact pressure and whether

the plate is precisely formed to the bone or

not. The loading is transferred directly from the

screw to the plate.

The locking system works due to the plastic

deformation of the plate on the screw head

thread while inserting the screw. The locking

system is reliable for repeated insertion of the

screw, for example when correcting the screw

angle or position.

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Operation A: Technique

1a. Fracture Reduction

2a. Choose and Position Plate • Remove plate from set: Remove an appropriate plate with the plate

holding forceps (007006) included in the set and hold it above the fracture.

• Shorten and bend plate: If there is no appropriate plate in the set, any plate can be matched by shortening and bending. If you bend the plate you have to ensure that the bending occurs at the bending zones in order to protect the locking holes.

• Position plate: If the plate geometrically fits, it should be positioned centrally on the fracture.

3a. Secure Position with K-Wires� If necessary, the position can be secured with 1.0 mm K-Wires using the

K-Wire holes in the plate.

4a. Determine Fixed Point (1st screw) and Pre-Drill We recommend fixing the first screw on one of the plate ends in order to

gradually fix the possibly multi-fractured bone with the plate.

• Select the drill guide (007005) according to the selected screw diameter.

• Connect the appropriate drill bit (1.3 mm no. 007007/resp. 1.7 mm no. (007008) to the drill machine and pre-drill bi-cortically through the drill guide with a tolerable maximum angle of 10°.

NOTE: Screws with 2.0 mm to be pre-drilled with 1.3 mm (007007). Screws with 2.4 mm to be pre-drilled with 1.7 mm (007008).

Technique 2.0/2.4 (Pre-operative planning using a sizing template)

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5a. Determine Screw Length with Depth Gauge • Insert the depth gauge (007009) • Measure the depth to the opposite cortical side • Read the screw length

6a. Remove Screw Out of the Tray • Connect self-retaining star drive screwdriver bit T6 (007004) to

AO-handle (007003)

• Fix the pre-assembled star drive screwdriver bit T6 with light pressure into the screw and remove it from the tray.

7a. Determine Fixed Point (1st screw) • Insert the selected screw (6a) into the pre-drilled screw hole (4a).

• In order to guarantee an optimum stability, insert the screw so that the screw head is flush with the plate surface.

8a. Set Remaining Screws Repeat steps 5a to 8a.

9a. Removal of Implants� • Loosen all implant screws • Remove all implant screws • Remove plate

NOTE: If the screws are not loosened before removing them, this causes

the plate to rotate whilst removing the last screw; resulting in damage to the soft tissue.

Technique 2.0/2.4 (Pre-operative planning using a sizing template)

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Operation B: Technique

1b. Fracture Reduction

2b. Choose and Position Plate� • Remove plate from set: Remove an appropriate plate with the

plate holding forceps (007006) included in the set and hold it above the fracture.

• Shorten and bend plate: If there is no appropriate plate in the set, any plate can be matched by shortening and bending. If you bend the plate you have to ensure that the bending occurs at the bending zones in order to protect the locking holes.

• Position plate: If the plate geometrically fits, it should be positioned centrally on the fracture.

3b. Secure Position with K-Wires� If necessary, the position can be secured with 1.0 mm K-Wires using

the K-Wire holes in the plate.

4b. Determine Fixed Point (1st screw) and Pre-Drill We recommend fixing the first screw on one of the plate ends in

order to gradually fix the possibly multi-fractured bone with the plate.

• Select the drill guide (007062) according to the selected screw diameter

• Connect the appropriate drill bit (2.0 mm no. 001018/resp. 2.5 mm no. 001019) to the drill machine and pre-drill bi-cortically through the drill guide with a tolerable maximum angle of 10°.

NOTE: Screws with 2.7 mm to be pre-drilled with 2.0 mm (001018). Screws with 3.5 mm to be pre-drilled with 2.5 mm (001019).

Technique 2.7/3.5

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5b. Determine Screw Length with Depth Gauge • Insert the depth gauge (007066) • Measure the depth to the opposite cortical side • Read the screw length

6b. Remove Screw • Connect self-retaining star drive screwdriver bit T15 (007061) to

AO-handle (007003)

• Hanging screws to be directly removed with the pre-assembled star drive screw bit T15 by fixing the srew with light pressure and removing it from the tray

• Lying screws to be removed with the included forceps (007006) and set into the assembly hole in the tray. Fix the pre-assembled star drive screw bit T15 with light pressure into the screw in the assembly hole and remove it from the tray.

7b. Determine Fixed Point (1st screw) • Insert the selected screw (6b) into the pre-drilled screw hole (4b). • In order to guarantee an optimum stability, insert the screw so that

the screw head is flush with the plate surface.

8b. Insert Remaining Screws Repeat steps 4b to 7b.

9b. Removal of Implants • Loosen all implant screws • Remove all implant screws • Remove plate

NOTE: If the screws are not loosened before removing them, this causes the

plate to rotate whilst removing the last screw; resulting in damage to the soft tissue.

Technique 2.7/3.5

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Clinical Indications• Fracture osteosynthesis and arthrodesis of extemities

• Fusion of vertebrae as a result of trauma

• TPO (triple pelvic osteotomy)

• Distal Fractures

• Mandibular Reconstructions

• Acetabular and Ilium Fractures

Pre-Op

Pre-Op

Post-Op

Post-Op

Post-Op

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Pre-Op

Pre-Op

Pre-Op

Post-Op

Post-Op

Post-Op

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Mechanical TestingTest I: 4-Point Bending according to ASTM F382-99Summary-FEM analysis of a 4-point bending test was performed according to ASTM F382-99. Testing was performed at our

manufacturing facility, in Germany, on December 7, 2009. The PAX 2.0, 2.4, 2.7 and 3.5mm plates were tested. In each case

the 8 hole plates was used.

Bending stiffness K (A1.3.1.4) the ASTM F382-99

K141-2401-08 = 50N ÷ 0,513mm = 93,5 N/mm

K141-2402-08 = 110N ÷ 0,601mm = 177,7 N/mm

K141-3501-08 = 125N ÷ 0,739mm = 169,1 N/mm

K141-3502-08 = 240N ÷ 0,850 mm = 282,4 N/mm

K = Load

Load_Point_Displacement

FIG. 1 4-Point�Testing�set-up

FIG. 2 Graph

Results:

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Test II: 4-Locking Break Out StrengthSummary- Testing was performed at our manufacturing facility, in Germany, on May14, 2010. The PAX 2.4 and 3.5mm

screws were tested. The locking screws were tested by an axial load until failure. The test configuration ensures that we

have as pure as an axial effect as possible to test specifically the locking interaction between the plate and the screw.

FIG. 1 4-Locking�Break�Out�Set-Up FIG. 2 Cad�Drawing�Indicationg�Load�Direction

FIG. 3 Break-out�Results

Results:

2.4mm 3.5mm

Locking Torque 0,5Nm 0,7Nm 1,0Nm 2,0Nm

Test 01 in [N] 580 829 569 988

Test 02 in [N] 578 914 654 969

Test 03 in [N] 530 852 546 >1007

Average value in [N] 563 865 590 988

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Mechanical TestingTest III: Locking Screw Angle StabilitySummary- Testing was performed at our manufacturing facility, in Germany, on May 14, 2010. The PAX 3.5mm screws and

plates were tested. In each case the 8 hole plates was used. The force was applied 15mm away from the locking point.

FIG. 1�4-Point�Testing�set-up

FIG. 2 Load�direction�15mm�from�locking�point

Results:

Test No.Force

[N] Locking Torque

001 - 2,0Nm 109.0

2,0Nm002 - 2,0Nm 114.0

003 - 2,0Nm 105.0

004 - 2,0Nm 113.0

Average 110.3

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Test IV: 4-Drive Torque Plate DeflectionSummary- Testing was performed at our manufacturing facility, in Germany, on May 14, 2010. The PAX 3.5mm plates and

screws were tested. In each case the 8 hole plates was used. The test shows the deflection of the plate over the drive torque.

Locking was compared to non locking and the plate deflection was observed.

FIG. 1�Pax�locking�screw�inserted�with�2.0Nm�of�torque.�Plate�deflection�was�observed�to�be�less�than�.23mm.�This�corresponds�to�approximately�45N�of�force�acting�on�the�bone.

FIG. 3�Screw�torque�v.s.�plate�deflection.�The�near�vertical�line�is�the�test�with�a�normal�screw�whereas�the�flat�line�is�the�Pax�locking�screw.�The�test�was�designed�to�illustrate�that�once�the�threads�begin�to�lock�there�is�minimal�axial�force�exerted�on�the�plate�and�therefore�the�bone.

FIG. 2�Normal�Screw�inserted�with�0.7Nm�of�torque.�Plate�deflection�was�observed�to�be�1.71mm.�This�corresponds�to�approximately�335N�of�force�acting�on�the�bone.

Results:

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Ordering InformationPAX Locking 2.0/2.4mm System 007000 VET 2.0/2.4 set

*All available instrument and implant sizes below:

PART# TRAY DESCRIRPTION

007001 Tray 2.0/2.4mm

007002 Tray - Cover

INSTRUMENTS

007003 QC Handle - Straight

007004 Stardrive Bit T6

007005 Drill Guide 1.3/1.7mm

007006 Plate Holding Forceps 140mm

007007 Drill Bit - 1.3 mm


007009 Depth gauge - 2.0/2.4mm screws

Includes: Qty Per Kit PAX 2.0/2.4 Tray 1PAX 2.0/2.4 Tray Cover 1QC Handle - Straight 1PAX Stardrive Screwdriver T6 2PAX Drill Guide 1.3/1.7mm 1PAX Plate Holding Forceps 140mm 1PAX 1.3mm QC Drill Bit 1PAX 1.7mm QC Drill Bit 1PAX Depth Gauge 2.0/2.4mm 1Screws 2.0mm, Lengths 6mm – 16mm 6 each sizeScrews 2.0mm, Lengths 18mm – 20mm 4 each sizeScrews 2.4mm, Lengths 6mm – 20mm 6 each size Straight Plates: 2.0mm, Holes: 5,6,7,8,9 1 each size Straight Plates: 2.4mm, Holes: 5,6,7,8,9 1 each size T-Plates: 2.0mm, Holes: 4,5,6,7,8,9 1 each size T-Plates: 2.4mm, Holes: 4,5,6,7,8,9 1 each size

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IMPLANTS (Plate) HOLES PER PLATE

2.0m

m S

trai

ght

Pla

teTh

ickn

ess:

1.5

mm

, W

idth

: 6.0

mm

007010 2.0mm Locking Straight Plate, 18mm 3








2.4m

m S

trai

ght

Pla

teTh

ickn

ess:

2.0

mm

, W

idth

: 7.5

mm

007018 2.4mm Locking Straight Plate, 24 mm 4









2.0m

m T

-Pla

teTh

ickn

ess:

1.5

mm

, W

idth

: 6.0

mm

007027 2.0mm Locking T-Plate, 17mm 4






2.4m

m T

-Pla

teTh

ickn

ess:

2.0

mm

, W

idth

: 7.5

mm







IMPLANTS (Screws)

2.0m

m S

crew

s

007039 2.0mm x 6mm Locking Screw








2.4m

m S

crew

s











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Ordering InformationPAX Locking 2.7/3.5mm System 007057 VET 2.7/3.5 Set

Includes: Qty Per KitPAX 2.7 Tray 1PAX 3.5 Tray 1PAX 2.7/3.5 Tray Cover 2PAX 2.7mm Screw Tray Insert 1PAX 3.5mm Screw Tray Insert 1QC Handle - Straight 1PAX Stardrive Screwdriver Bit T15 1PAX Drill Guide 2.0/2.5mm 1PAX Plate Holding Forceps 140mm 1PAX 2.0mm QC Drill Bit 1PAX 2.5mm QC Drill Bit 1PAX Depth Gauge 2.7/3.5mm 1Screws: 2.7mm, Lengths 18mm - 28mm 5 each size Screws: 3.5mm, Lengths 20mm - 40mm 5 each size Straight Plate: 2.7mm, Holes: 5,6,7,8,9 1 each size Straight Plate: 3.5mm, Holes: 5,6,7,8,9 1 each size

*All available instrument and implant sizes below:

PART# TRAY DESCRIRPTION

007058 Tray 2.7

007158 Tray 3.5

007059 Tray - Cover

007258 Tray - 2.7mm Screws

007358 Tray - 3.5mm Screws

INSTRUMENTS

007003 QC Handle - Straight

007061 Stardrive Bit T15

007062 Drill Guide 2.0/2.5mm

007006 Plate Holding Forceps 140mm



007066 Depth gauge - 2.7/3.5mm screws

Optional: PAX Implant Set for 2.7/3.5mm (#007116)Straight Plate: 2.7mm, Holes: 4,10,12 Qty# 1Straight Plate: 3.7mm, Holes: 10,11,12 Qty# 1Screws: 2.7mm, Lengths: 8mm – 16mm Qty# 5Screws: 2.7mm, Lengths: 30mm – 38mm Qty# 2Screws: 3.5mm, Lengths: 8mm – 18mm Qty# 5Screws: 3.5mm, Lengths: 42mm – 50mm Qty# 2

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IMPLANTS (Plate) HOLES PER PLATE

2.7m

m P

late

sTh

ickn

ess:

2.5

mm

, W

idth

: 9.0

mm

002804 2.7mm Locking Straight Plate, 36mm 4002805 2.7mm Locking Straight Plate, 45mm 5002806 2.7mm Locking Straight Plate, 54mm 6002807 2.7mm Locking Straight Plate, 63mm 7002808 2.7mm Locking Straight Plate, 72mm 8002809 2.7mm Locking Straight Plate, 81mm 9002810 2.7mm Locking Straight Plate, 90mm 10002812 2.7mm Locking Straight Plate, 108mm 12007067 2.7mm Locking Straight Plate, 126mm 14007068 2.7mm Locking Straight Plate, 144mm 16

3.5m

m P

late

s Th

ickn

ess:

3.2

mm

, W

idth

: 11.

0mm

001941 3.5mm Locking Straight Plate, 44mm 4001942 3.5mm Locking Straight Plate, 55mm 5001943 3.5mm Locking Straight Plate, 66mm 6001944 3.5mm Locking Straight Plate, 77mm 7001945 3.5mm Locking Straight Plate, 88mm 8001946 3.5mm Locking Straight Plate, 99mm 9001947 3.5mm Locking Straight Plate, 110mm 10001948 3.5mm Locking Straight Plate, 121mm 11001949 3.5mm Locking Straight Plate, 132mm 12007071 3.5mm Locking Straight Plate, 154mm 14007072 3.5mm Locking Straight Plate, 165mm 15007073 3.5mm Locking Straight Plate, 176mm 16007074 3.5mm Locking Straight Plate, 198mm 18007075 3.5mm Locking Straight Plate, 220mm 20

IMPLANTS (Screws)

2.7m

m S

crew

s

002485 2.7mm x 8mm Locking Screw002486 2.7mm x 10mm Locking Screw002487 2.7mm x 12mm Locking Screw002488 2.7mm x 14mm Locking Screw002489 2.7mm x 16mm Locking Screw002490 2.7mm x 18mm Locking Screw002491 2.7mm x 20mm Locking Screw002492 2.7mm x 22mm Locking Screw002493 2.7mm x 24mm Locking Screw002494 2.7mm x 26mm Locking Screw002495 2.7mm x 28mm Locking Screw002496 2.7mm x 30mm Locking Screw002497 2.7mm x 32mm Locking Screw002498 2.7mm x 34mm Locking Screw002499 2.7mm x 36mm Locking Screw007077 2.7mm x 38mm Locking Screw007078 2.7mm x 40mm Locking Screw007079 2.7mm x 45mm Locking Screw007080 2.7mm x 50mm Locking Screw

3.5m

m S

crew

s

007081 3.5mm x 8mm Locking Screw007082 3.5mm x 10mm Locking Screw007083 3.5mm x 12mm Locking Screw007084 3.5mm x 14mm Locking Screw007085 3.5mm x 16mm Locking Screw007086 3.5mm x 18mm Locking Screw007087 3.5mm x 20mm Locking Screw007088 3.5mm x 22mm Locking Screw007089 3.5mm x 24mm Locking Screw007090 3.5mm x 26mm Locking Screw007091 3.5mm x 28mm Locking Screw007092 3.5mm x 30mm Locking Screw007093 3.5mm x 32mm Locking Screw007094 3.5mm x 34mm Locking Screw007095 3.5mm x 36mm Locking Screw007096 3.5mm x 38mm Locking Screw007097 3.5mm x 40mm Locking Screw007098 3.5mm x 42mm Locking Screw007099 3.5mm x 44mm Locking Screw007100 3.5mm x 46mm Locking Screw007101 3.5mm x 48mm Locking Screw007102 3.5mm x 50mm Locking Screw007103 3.5mm x 52mm Locking Screw007104 3.5mm x 54mm Locking Screw007105 3.5mm x 56mm Locking Screw

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Plate Sizing Templates

MM SCALE8070600 5040302010

MAG@3%

Straight Plates

007017

007016

007015

007014

007013

007012

007010

007011

T - Plates

007027

007028

007029

007030

007031

007032

Template 2.0VET-002 Rev.B 2010-04-09

Template 2.0

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MM SCALE8070600 5040302010

MAG@3%

Template 2.4

Straight Plates

007026

007025

007024

007023

007022

007021

007020

007019

007018

007038

T - Plates

007037

007036

007035

007034

007033

VET-002 Rev.B 2010-04-09MM SCALE

8070600 5040302010MAG@3%

Template 2.4

Straight Plates

007026

007025

007024

007023

007022

007021

007020

007019

007018

007038

T - Plates

007037

007036

007035

007034

007033

VET-002 Rev.B 2010-04-09

Template 2.4

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MM SCALE

MAG@3%

002805

Template 2.7

Straight Plates

007068

007067

002812

002810

002809

002808

002807

002806

002804

Plate Sizing TemplatesTemplate 2.7

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MM SCALE

MAG@3%

007073

007071

007072

001949

001948

001947

001946

001945

001944

001943

001942

001941

Straight Plates

Template 3.5

Abgelöste SolidWorks Zeichnung - Nicht synchroner Druck

Template 3.5

SECUROS USA443�Main�StreetFiskdale,�Ma�01518�Tel:�(877)�BONEFIx�(266-3349)Fax:�(508)�347-5330Email:�[email protected]

SECUROS Europe GmbH Take�Off�Gewerbepark�4�78579�Neuhausen�Ob�Eck��GermanyTel.:�+49�7467�9476��50Fax:�+49�7467�9476��52�Email:�[email protected]

Osteosynthesis Set - DMV · 2013. 10. 26. · The osteosynthesis set is designed for a operative...

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