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Mandible External Fixator II.Provides treatment for fractures of themaxillofacial area.

Technique Guide

This publication is not intended fordistribution in the USA.

Instruments and implants approved by the AO Foundation.

Mandible External Fixator II Technique Guide DePuy Synthes 1

WarningThis description is not sufficient for immediate application ofthe instrumentation. Instruction by a surgeon experienced inhandling this instrumentation is highly recommended.

Table of Contents

Image intensifier control

Introduction

Surgical Technique

Product Information

Mandible External Fixator II 2

AO Principles 4

Indications 5

Fixation Using Schanz Screws 6

Optional Technique to Implant Schanz Screws 17

Alternative Frame Configurations 20

Instruments 22

Set 26

Mandible External Fixator II

The Mandible External Fixator II allowsthe surgeon to create a rigid constructusing three basic components: 4.0 mmrods, 2.5 mm Kirschner wires and/or 2.5 mm/4.0 mm Schanz screws, and adjustable snap-on clamps.

2.5 mm Kirschner Wires (292.750)For fixation of fragments that may betoo small for 4.0 mm Schanz screws.

4.0 mm Titanium Connecting Rods(04.305.100–04.305.103)– Pre-bent to shape of mandible

– Available in four sizes

– Can be contoured to match patientanatomy

Combination Clamp (03.305.006)– Accepts a 2.5 mm/4.0 mm Schanz

screw, 2.5 mm Kirschner wire, or 4.0 mm rod on each end of the clamp

– Snap-on design allows clamp placement between previously applied clamps

– Connects two rods in any orientation, for greater versatility of Schanz screw/Kirschner wire place-ment and frame construction

– Maintains rod position during frameassembly and fracture reduction

Features– Lightweight single-phase system

– Adjustable throughout application

2 DePuy Synthes Mandible External Fixator II Technique Guide

* Ti-6Al-7Nb

2.5 mm/4.0 mm Titanium Schanz Screws(04.305.128–04.305.142)– For Symphysis, Body and Ramus–two thread lengths

per region

– Self-drilling threads allow direct screw implantation, or predrilling if desired

– Shoulder prevents over-insertion

– Biocompatible titanium alloy*


AO Principles

In 1958, the AO formulated four basic principles which havebecome the guidelines for internal fixation.1 Those princi-ples, as applied to the Mandible External Fixator II, are:

Anatomic reductionConstruct adjustability allows optimal reduction of the fracture or osteotomy.

Stable fixationClamps, screws, wires and rods provide stability to fractured region.

Preservation of blood supplyPlacement of Schanz screws does not require stripping orcompression of the periosteum.

Early mobilizationConstruct features combined with AO technique create an environment for bone healing, expediting a return to optimal function.

1 M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger. AO Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991.


Photo courtesy of Daniel Buchbinder, DMD, MD Chief, Division of MaxillofacialSurgery, Continuum Cancer Centers of New York

Indications

The Mandible External Fixator II is intended to stabilizeand provide treatment for fractures of the maxillofacial area,including:

– Severe open mandibular fractures– Highly comminuted closed fractures– Nonunions and delayed unions

(especially associated with infection)– Fractures associated with infection– Tumor resections– Facial deformity corrections– Gunshot wounds– Panfacial fractures– Burn maintenance– Bone grafting defects

Caution: This device has not been evaluated for the safetyand compatibility in the MR environment. The device has notbeen tested for heating or migration in the MR environment.


Fixation Using Schanz Screws

1Patient preparation

Place the patient in maxillomandibular fixation when appropriate.

2Identify appropriate rods

Identify the appropriate rod or combination of rods forfixation. In most cases, the pre-bent rods will not needadditional contouring. If contouring is needed, followsteps 3–4, otherwise proceed to step 5.

3Contour the bending template

Instrument

03.305.009 Bending Template for Connecting Rods � 4.0 mm

Contour the bending template to match the patient’s bonyanatomy.

Note: The rod should be positioned approximately one fin-gerbreadth away from the patient’s skin, evenly throughoutthe entire length of the rod.


4Contour the rod(s)

Instrument

03.305.007 Bending Pliers for Connecting Rods � 4.0 mm

Using the bending pliers, contour the selected pre-bent rodto match the rod template.

5Verify fit and screw location

Verify the fit of the pre-bent rod on the patient. Identify thedesired Schanz screw locations for the first and last screw(furthest from the defect on the proximal and distal side) andmark accordingly.

Note: A minimum of two Schanz screws per segment (twoscrews in greatest segment and two in other segments) isrecommended to ensure adequate stability. Optimal locationof Schanz screws will place one screw 10 mm distal and another screw 10 mm proximal to the defect.

Increase bend Decrease bend



6Make small stab incision

Prepare for Schanz screw insertion by making a small stab incision at the first marked screw location.

7Dissect soft tissue

Instruments

03.305.025 Trocar � 4.0 mm

03.305.026 Drill Guide/Cannula � 4.0 mm

395.911 Handle for Drill Sleeve

Thread the cannula into the handle. Insert the trocar into thehandle/cannula assembly. Bluntly dissect the soft tissue andpass the cannula and trocar through the stab incision to thebone.

Remove the trocar, leaving the cannula in place.


8Implant Schanz screw

Instrument

03.305.024 Adapter with Rapid Driver for Schanz Screws � 4.0 mm, with Hexagonal Coupling

Also available with Quick Coupling

393.101 Adapter for Seldrill Schanz Screw � 4.0 mm

Select the appropriate Schanz screw. The Schanz screws areself-drilling, but if predrilling is desired, refer to the optionaltechnique on pages 17–19.

Secure the adapter into the chuck of a power drill, then loadthe Schanz screw into the adapter. Using the cannula as aguide, drive the Schanz screw into the mandible down to thestop. Pull on the drill to disengage the adapter from the im-planted Schanz screw.

Note: Synthes recommends using the Compact Air Drive II oran equivalent drill with an operating speed of approximately900 RPM.



Optional technique

Instruments

03.305.027 Adapter for Schanz Screws � 4.0 mm, for Handles with Hexagonal Coupling

311.023 Ratcheting Screwdriver Handle, with Hexagonal Coupling

395.350 Combination Wrench � 7.0 mm

395.360 Socket Wrench � 7.0 mm

Load the adapter for Schanz screws � 4.0 mm into theratcheting screwdriver handle. Slide the adapter over the ex-posed end of the Schanz screw. Hand-tighten the thumb-screw on the adapter to capture the Schanz screw. Using thecombination wrench or socket wrench, tighten the thumb-screw at least 1/4 turn. Use the ratcheting screwdriver han-dle to complete the implantation of the Schanz screw.

8Implant Schanz screw (continued)

Instruments

03.305.024 Adapter With Rapid Driver for Schanz Screws � 4.0 mm, with Hexagonal Coupling


If the Schanz screw requires additional tightening, load theother adapter with rapid driver into the ratcheting screw-driver handle. Engage the exposed end of the Schanz screwand ratchet the handle clockwise until the Schanz screw isfully inserted. Pull back on the handle to disengage theSchanz screw.


9Implant second Schanz screw

Position and insert the second Schanz screw on the oppositeside of the defect and furthest from the defect as outlined insteps 6–8.


10Assemble the rigid construct

Implant

03.305.006 Combination Clamp

Snap combination clamps onto both Schanz screws and rod.

Verify the correct alignment before proceeding.

Reduce the fracture and tighten the clamp nuts.



11Add third clamp

Attach a third clamp to the rod approximately 10 mm proximal or distal to the defect.

Insert the cannula into the clamp, as shown. Angle the cannula and clamp for the desired screw placement. Markthe incision site.

Temporarily rotate the cannula and clamp upward to mini-mize obstruction while making the incision. Make a small incision and bluntly dissect the soft tissue. Rotate the clampand cannula to the original position. Insert the trocar andpass the cannula through the incision to the bone. Removethe trocar. Tighten the clamp, securing the cannula to therod.

Note: Do not overtighten the clamp, as this will result indamage to the cannula.


12Implant third Schanz screw

Insert a Schanz screw as outlined in steps 6–8. Loosen theclamp slightly and slide the cannula off the Schanz screw.

With the clamp capturing the Schanz screw and the rod,tighten the clamp nut.



Insert all remaining Schanz screws to complete the frame,as outlined in steps 11–12.

13Complete the construct

Note: A minimum of two Schanz screws are required oneach side of the defect.


15Option: Trim Schanz screws and rod

Instruments

388.720 Bolt Cutter (large)

359.217 Cutter (small)

392.240 or Protective Caps 394.990

Trim the Schanz screws or rod, if necessary, using the boltcutter. Place protective caps over the cut ends.

14Verify reduction and adjust

Verify reduction and alignment. If adjustment is needed,loosen the clamp nuts, manipulate the mandible, andretighten the clamps.



1Predrill the bone

Instrument

03.305.004 Drill Bit � 1.8/4.0 mm with Stop, for J-Latch Coupling

Also available with Mini Quick Coupling

03.305.011 Drill Bit � 1.8/4.0 mm with Stop, for Mini Quick Coupling

Use the drill bit through the cannula to drill into the bone.

Note: Synthes recommends using the Compact Air Drive II oran equivalent drill with an operating speed of approximately900 RPM.

Optional Technique to Implant Schanz Screws

2Use measuring device

Instrument

03.305.005 Measuring Device

Insert the measuring device through the cannula and hookthe lingual cortex of the mandible. Record the number indicated on the measuring device.

Note: The reading from the device does not represent thebone thickness.

Remove the measuring device from the cannula.


Optional Technique to Implant Schanz Screws

3Select and measure Schanz screw

Select the appropriate Schanz screw for the patient’s bonyanatomy.

Slide the selected Schanz screw into the cannulated end ofthe measuring device and align the tip of the Schanz screwwith the number recorded in step 2.

4Load Schanz screw

Instruments

03.305.027 Adapter for Schanz Screws � 4.0 mm, for Handles with Hexagonal Coupling




Optional instrument

03.305.008 T-Handle, cannulated, for Schanz Screws � 4.0 mm

Slide the adapter over the exposed end of the Schanz screw.Hand-tighten the thumbscrew on the adapter to securethe Schanz screw. Using the combination wrench or socketwrench, tighten the thumbscrew at least 1/4 turn.

Load the adapter into the ratcheting screwdriver handle.

Option: Use the cannulated T-handle for manual screwinsertion.


5Implant Schanz screw

With clockwise rotation, insert the Schanz screw through the cannula until the adapter contacts the cannula, ensuringproper implant depth.

6Remove adapter from implanted Schanz screw

Remove the adapter from the Schanz screw by loosening the thumbscrew with either the combination wrench or the socket wrench.

Remove the cannula.


Alternative Frame Configurations

Modular carbon fiber frame As applied on an infected angle fracture. The modular carbon fiber frame provides improved x-ray imaging.

Items to build construct Quantity

03.305.006 Combination Clamp, for Mandible External Fixator, 6

Titanium Alloy (TAV)

395.600 Connecting Rod � 4.0 mm, length 60 mm, 2

Carbon Fibre

395.610 Connecting Rod � 4.0 mm, length 80 mm, 1

Carbon Fibre

04.305.134– Schanz Screw � 4.0/2.5 mm, self-drilling, 2

04.305.138 for mandible body, Titanium Alloy (TAN)

One-half frame As applied on an infected angle fracture.


03.305.006 Combination Clamp,for Mandible 4

External Fixator, Titanium Alloy (TAV)

04.305.103 Connecting Rod � 4.0 mm, prebent, 1

1⁄2 mandible, Titanium Alloy (TAN)


04.305.130 for ramus, Titanium Alloy (TAN)


04.305.138 for mandible body Titanium Alloy (TAN)


Double-stacked frame As applied on a resected mandible.






04.305.100 Connecting Rod � 4.0 mm, prebent, full mandible 1

with ramus, Titanium Alloy (TAN)

04.305.128– Schanz Screw � 4.0/2.5 mm, self-drilling, for ramus, 2

04.305.130 Titanium Alloy (TAN)



04.305.140 Schanz Screw � 4.0/2.5 mm, self-drilling, 1

or for symphysis, Titanium Alloy (TAN)

04.305.142

Modular frameAs applied on a comminuted fracture. A modular frame can be created to accommodate the fracture location.






04.305.101 Connecting Rod � 4.0 mm, prebent, full 1

mandible, Titanium Alloy (TAN)

04.305.128 Schanz Screw � 4.0/2.5 mm, self-drilling, 2

or for ramus, Titanium Alloy (TAN)

04.305.130




04.305.142 for symphysis, Titanium Alloy (TAN)


03.305.007 Bending Pliers for Connecting Rods � 4.0 mm

For contouring pre-bent titanium rods

03.305.009 Bending Template for Connecting Rods � 4.0 mm

Facilitates contouring the pre-bent titanium rods

Instruments

03.305.004 Drill Bit � 1.8/4.0 mm with Stop, for J-Latch Coupling

03.305.011 Drill Bit � 1.8/4.0 mm with Stop, for Mini Quick Coupling

Drills pilot holes for Schanz screws

03.305.005 Measuring Device

Ensures proper Schanz screw insertiondepth when predrilling


03.305.027 Adapter for Schanz Screws � 4.0 mm,for Handles with Hexagonal Coupling

For the manual insertion of Schanz screwsand removal of trimmed Schanz screwsusing the Ratcheting Screwdriver Handle(311.023)

03.305.024 Adapter with Rapid Driver for SchanzScrews � 4.0 mm, with Hexagonal

Coupling

393.101 Adapter for Seldrill Schanz Screw� 4.0 mm, with Quick Coupling

– Used with power drills or RatchetingScrewdriver Handle (311.023)* toimplant Schanz screws

– Allows quick release from Schanz screws after implantation

03.305.025 Trocar � 4.0 mm

Used with Drill Guide/Cannula(03.305.026) to help pass through softtissue

03.305.026 Drill Guide/Cannula � 4.0 mm

Protects soft tissue during insertion ofSchanz screws

*only with 03.305.024



Instruments

311.023 Ratcheting Screwdriver Handle,with Hexagonal Coupling

For use with Adapter for Handles withHexagonal Coupling (03.305.027) orAdapter with Rapid Driver (03.305.024)for the insertion of Schanz screws


For tightening nuts on clamps and thethumbscrew on the Adapter for Handleswith Hexagonal Coupling (03.305.027)

395.911 Handle for Drill Sleeve

Used to control the Drill Guide/Cannula(03.305.026)


For tightening nuts on clamps and thethumbscrew on the Adapter for Handleswith Hexagonal Coupling (03.305.027)


Set

Set01.305.001 Mandible External Fixator II

Graphic Cases306.720 Graphic Case for

Mandible External Fixator II306.721 Lid for Graphic Case for

Mandible External Fixator II No. 306.720

Schanz Screws04.305.128 Schanz Screw � 4.0/2.5 mm, self-drilling,

for ramus, thread length 8 mm,Titanium Alloy (TAN)

04.305.130 Schanz Screw � 4.0/2.5 mm, self-drilling,for ramus, thread length 10 mm, Tita-nium Alloy (TAN)

04.305.134 Schanz Screw � 4.0/2.5 mm, self-drilling,for mandible body, thread length 14 mm,Titanium Alloy (TAN)

04.305.138 Schanz Screw � 4.0/2.5 mm, self-drilling,for mandible body, thread length 18 mm,Titanium Alloy (TAN)

04.305.140 Schanz Screw � 4.0/2.5 mm, self-drilling,for symphysis, thread length 20 mm, Titanium Alloy (TAN)

04.305.142 Schanz Screw � 4.0/2.5 mm, self-drilling,for symphysis, thread length 22 mm, Titanium Alloy (TAN)

Wires292.750 Kirschner Wire � 2.5 mm with threaded

tip, length 150/15 mm, Stainless Steel

Connecting Rods04.305.100 Connecting Rod � 4.0 mm, prebent, full

mandible with ramus, Titanium Alloy (TAN)04.305.101 Connecting Rod � 4.0 mm, prebent, full

mandible, Titanium Alloy (TAN)04.305.102 Connecting Rod � 4.0 mm, prebent,

3⁄4 mandible, Titanium Alloy (TAN)04.305.103 Connecting Rod � 4.0 mm, prebent,



395.600 Connecting Rod � 4.0 mm, length 60 mm, Carbon Fibre




Clamps03.305.006 Combination Clamp, for Mandible External

Fixator, Titanium Alloy (TAV)

Protective Caps392.240 Protective Cap for Kirschner Wire

� 2.5 mm394.990 Protective Cap for Connecting Rod

� 4.0 mm

Instruments03.305.004 Drill Bit � 1.8/4.0 mm with Stop,

length 125/20 mm, 2-flute, for J-Latch Coupling

03.305.005 Measuring Device for Mandible ExternalFixator

03.305.007 Bending Pliers for Connecting Rods � 4.0 mm, for Mandible External Fixator

03.305.009 Bending Template for Connecting Rods � 4.0 mm, for Mandible External Fixator

03.305.024 Adapter with Rapid Driver for SchanzScrews � 4.0 mm, with Hexagonal Coupling, for Mandible External Fixator II

03.305.025 Trocar Ø 4.0 mm, for Mandible ExternalFixator II

03.305.026 Drill Guide/Cannula � 4.0 mm,for Mandible External Fixator II

03.305.027 Adapter for Schanz Screws � 4.0 mm,for Handles with Hexagonal Coupling,for Mandible External Fixator

311.023 Ratcheting Screwdriver Handle,with Hexagonal Coupling

395.350 Combination Wrench � 7.0 mm395.360 Socket Wrench � 7.0 mm395.911 Handle for Drill Sleeve


* These items will not fit in the Mandible External Fixator II Graphic Case.

Alternative Instruments03.305.011 Drill Bit � 1.8/4.0 mm with Stop,

length 125/20 mm, 2-flute, for Mini Quick Coupling

393.101 Adapter for Seldrill Schanz Screw � 4.0 mm, with Quick Coupling

Also available*03.305.008 T-Handle, cannulated, for Schanz Screws

� 4.0 mm03.305.500S Connecting Rod � 4.0 mm, straight,

length 500 mm (incl. Bending Template)388.720 Bolt Cutter (large)359.217 Cutter (small)395.640 Connecting Rod � 4.0 mm,

length 140 mm, Carbon Fibre395.650 Connecting Rod � 4.0 mm,



length 200 mm, Carbon Fibre

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Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.synthes.com/lit ©

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Mandible External Fixator II. Provides treatment for ...synthes.vo.llnwd.net/o16/LLNWMB8/INT...

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