stryker variax fibula ot

Operative Technique

KnifeLight Carpal Tunnel Ligament Release

VariAxFibula Locking Plate System

Operative Technique• Distal Fibula Fracture Repair

• PolyaxialLockingTechnology

• LowProfileDesign

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Tibia & Fibula

Contributing SurgeonBradley R. Merk, MD Associate Professor of Orthopaedic Surgery Director of Orthopaedic Trauma Feinberg School of Medicine Northwestern University

Chicago, USA

VariAx Fibula

This publication sets forth detailed recommended procedures for using Stryker Osteosynthesis devices and instruments.

It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required.

A workshop training is required prior to first surgery.

All non-sterile devices must be cleaned and sterilized before use. Follow the instructions provided in our reprocessing guide (L24002000). Multi-component instruments must be disassembled for cleaning. Please refer to the corresponding assembly/disassembly instructions.

See package insert for a complete list of potential adverse effects, contraindications, warnings and precautions. The surgeon must discuss all relevant risks, including the finite lifetime of the device, with the patient, when necessary.

Warning:FixationScrews:StrykerOstreosynthesisbonescrewsarenotapprovedorintendedforscrewattachmentorfixationtotheposteriorelements(pedicles)ofthecervical,thoracicorlumbarspine.

2

Introduction 4

2. Features&Benefits 5

3. Overview 6

Plate Options 6

Screw Options 6

4. Indications,Precautions&Contraindications 7

5. OperativeTechnique 8

Planning and Preparation 8

Preparation for Screw Insertion 10

Screw Insertion 13

Final Steps 13

Optional: Independent Lag Screw Technique 14

Optional: Syndesmotic Screw Fixation Technique 16

OrderingInformation-Implants 17

OrderingInformation-Instruments 20

OrderingInformation-Cases&Trays 23

Table of Contents

3

•TheVariAxFibulaLockingPlate Systemrepresentsanewgeneration ofimplanttechnology The reconstruction and fixation of distal fibular fractures can now be enhanced by means of the patented SmartLock polyaxial lock-ing mechanism. This powerful feature allows a surgeon to insert polyaxial locking or non-locking screws at variable angles with respect to the plate, so that they can be targeted to address the location and geometry of any given fracture, without the constraint of existing monoaxial plate designs or screw trajectories.

•PatentedPolyaxialLockingTechnology

Each screw is made of titanium alloy, which is slightly harder than the plates. When a locking screw is used, the thread in the head of the screw re-shapes the titanium used in the plate, thus allowing for a secure form-fitting geometry. This process is designed to result in a solid, locked connection between the head of the screw and the plate.

•One-StepLocking Achieved by simply inserting a

locking screw within the polyaxial locking range of ±15°, without the need for further steps.

•ModularSystemDesign The modular instrumentation system

is designed for seamless integration of other products from the Stryker Foot portfolio.

•Color-CodingofInstruments The instruments are color-coded to

facilitate ease-of-use during surgery.

The SmartLock Locking Technology is patented (US 6,322,562; DE 43 43 117; EP 1 143 867) by Professor Dietmar Wolter, Hamburg, Germany.

Introduction

-15° +15°

4

• Pre-contouredPeriarticular PlateDesign

The pre-contoured shape of the VariAx Fibula Plates was carefully designed using a comprehensive CT scan database of human fibulas. The end result is a pre-contoured plate that closely matches the average anatomical shape of the distal fibula, and thus requires minimal intra-operative plate contouring*.

• LowProfilePlateDesignand ReducedScrewHeadProminence

Each plate is designed to minimize soft tissue irritation by having a low profile design (only 1.3mm distally, and 2.0mm in the shaft portion). Furthermore, the screws are designed to have minimal head prominence when fully inserted in a plate, which helps further reduce the risk of irritation.

• K-WireHolesinthePlateTo allow for temporary fixation in order to ease plate application.

• AClusteringofDistalScrewsAllows for multiple points of fixation to treat comminuted fractures or fractures with limited distal bone stock.

• Full-Rangeof3.5mmLocking andNon-LockingScrews

Offers intra-operative solutions to cover a broad range of clinical situations.

• PolyaxialDrillGuideAllows placement of locking screws at a variable angle (up to ± 15°).

• EfficientT10ScrewHeadDesign All 3.5mm VariAx Fibula Locking Plate screws are designed with a T10 head. This screw head design facilitates efficient force transmis-sion from the screwdriver blade to the screw, and helps reduce the risk of screw head stripping.

• AnodizationTypeII

• OptionalIndependentLag ScrewFixation

A full range of non-locking VariAx screws are available for placement of independent lag screws.

Features & Benefits

* MEM Research Center ISTB Fibula Bone Implant Fitting Project.

5

Plate Options

FibulaPlate

Thefibulaplateonlyaccepts3.5mmscrews

Overview

3.5mmLocking

3.5mmNon-

Locking

Range 3 Holes - 12 HolesLength 77mm - 185mm

Screw Options

6

Indications, Precautions & Contraindications

The following contraindications may be of a relative or absolute nature, and must be taken into account by the at-tending surgeon:

• Inadequate bone quantity and qual-ity.

• Patients with active infections.

• Patients with metal allergies and foreign body sensitivity.

• Severely non-compliant patients with mental or neurological conditions who are unwilling or incapable of following post-operative care instructions.

• Patients with limited blood supply or insufficient quality or quantity of bone.

• Patients with unstable physical and/ or mental health conditions.

• Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself.

• Patients having inadequate tissue coverage over the operative site.

• Bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices.

• Other medical or surgical conditions which would preclude the potential benefit of surgery.

The VariAx Distal Lateral Fibula Plate is intended for use in internal fixation of the distal fibula.

Examples of Applications

• Weber A, B, C fractures of the distal fibula with and without syndesmotic injury.

• Distal Fibula non-unions and malunions.

IndicationsSee package insert for warnings, precautions, adverse effects and other essential product information.

The VariAx Fibula System has not been evaluated for safety and compatibility in the MR environment. The VariAx Fibula System has not been tested for heating or migration in the MR environment.

Warnings and Precautions

Contraindications

7

Planning and Preparation

The Operative Technique listed below is designed to provide a general overview on the instruments and procedure required to implant a VariAx Fibula Plate.

Clear identification and classification of the fracture site should first be established pre-operatively using the appropriate methods and visualization.A lateral incision is typically used to perform an extra-periosteal exposure of the distal fibula. A direct reduction and provisional fixation of the fracture can frequently be achieved. If the fracture morphology is amenable, an independent lag screw can be inserted first (see page 14). Alternatively,indirect reduction techniques may be employed such as a distal lateral fibula plate.

VariAx Fibula Plates can be removed from the plate tray and handled using the Forceps (64-20129), as shown.

Although the plates are pre-contoured, additional contouring of the plates is possible using the Plate Bending Pliers (45-80010) when required based on local patient factors or anatomy. In order to reduce the likelihood of stress riser effect and reduce the fatigue properties of the implant, care should be taken to bend the plate in between holes.

Note:Excessiveplatebendingmay leadtofailureofthelocking mechanismandshouldbe avoided.

Operative Technique

8

Having achieved reduction, the plate is selected and applied to the direct lateral surface of the distal fibula. The position should be adjusted to optimize fit and to allow for optimal screw fixation as per the fracture pattern and the pre-operative plan.Fluoroscopy can be utilized as needed to confirm position. The plate can then be stabilized by the insertion of K-Wires to ensure anatomical alignment (proximally and distally).

VariAx Fibula Plates include K-Wire holes that are designed to accommodate 1.4mm Trocar Tipped K-Wires (45-80200), for use in temporarily stabilizing the plate to bone.

The K-Wire Cutting Pliers (45-80020) can be used to cut the K-Wires to the desired length. This instrument includes a silicon inlay which prevents the cut end of a K-Wire from being ejected from the instrument.

Operative Technique

9

A drill guide must first be placed into a corresponding plate screw hole (in a plate), prior to pre-drilling a pilot hole. The Drill Guide for Circular Locking Holes (45-80001) must be used in all VariAx Fibula Plate holes. Use the end of the drill guide indicated with yellow color-coded lines to pre-drill for VariAx Fibula plating procedures. Yellow color-coding is associated with 3.5mm VariAx Foot and Ankle screws.

Pleasenote:Theotherendofthedrillguide isindicatedwithblackcolor- codedlines,andisdesignedfor usewithVariAxFootandAnklePlatesthataccept2.7mmscrews.Thisendofthedrillguidemust notbeusedforVariAxFibula procedures.

The drill guide is designed to limit drilling to a ±15° angle with respect to the plate. Drilling at an angle greater than ±15° may prevent locking from taking place, and should be avoided.

Always use the drill guide when pre-drilling a pilot hole, either for a locking or non-locking 3.5mm screw.

Note:Drillguidesshouldalwaysfit securelywithinascrewhole–a mis-matchbetweenthedrillguideandtheplateholeindicatesthat thewrongdimensiondrillguide hasbeenchosen.

Preparation for Screw Insertion

Operative Technique

10

Use the drill to create a pilot hole through the drill guide. The 2.6mm Twist Drill (45-35010) is color-coded yellow to match the color associated with the 3.5mm drill guide.

Although the locking and non-locking screws found in the VariAx Foot and Ankle system are self-tapping, when encountering hard bone a tap may be required. For 3.5mm screws the appropriate tap is similarly color-coded yellow (45-35005).

Measure the depth of the pre-drilled hole using the Depth Gauge for 3.5mm screws (45-35001). As with the drills and drill guides, the appropriate depth gauge is color-coded with yellow lines indicating use with 3.5mm screws. Always measure the depth of the pre-drilled hole by inserting the depth gauge first through the plate, and then into the pre-drilled hole.

Use depth gauge to attain appropriate screw length. The sleeve of the depth gauge must be fully inserted into therespective plate hole prior to measuring. Measuring without a plate will result in a false reading.

Operative Technique

11

Holding sleeves for screws can be used to securely attach a screw to the screwdriver during screw insertion. The yellow color-coded Holding Sleeve for 3.5mm screws (45-35030), must be used. Assemble the appropriate hold-ing sleeve and slide it over the screw-driver until it engages, as shown.

Assemble the appropriate Screwdriver Blade (with AO fitting) with the Screwdriver Handle, Revolving/Rigid, AO (45-85000).

Pleasenote:Onlytheyellowcolor-coded ScrewdriverBlade,AO,T10 (45-35015)isusedtoinsert3.5mm screws.

Begin by pushing the AO quick-connect sleeve towards the body of the Screwdriver Handle, insert the screw-driver blade into the AO quick-connect coupling, and then release the sleeve.

Operative Technique

Push the holding sleeve back so that the tip of the screwdriver becomes visible. Engage the screwdriver tip with the head of the chosen screw, then push the holding sleeve forward, as shown. The holding sleeve will engage with the head of the screw, firmly holding it in place. The screw can then be removed securely from the screw rack, and the screw can be inserted into the plate.

12

Screw InsertionInsert the screw into the pre-drilled hole using the screwdriver assembly.

As the screw head approaches the plate, draw the holding sleeve back from the screw head, and continue with final tightening then remove the screwdriver from the screw.

Repeat drilling, measuring, and placement of locking or non-locking screws in the remaining holes, as required. Always remember to use the appropriate sized drill guide.

Operative Technique

Final Steps• The highly efficient T10 interface (for 3.5mm screws) facilitates effective transmission of torque from the screwdriver blade to the screw.

• Intra-operative fluoroscopy is performed to confirm appropriate reduction and implant placement.• Additional surgical approaches and fixations (e.g. for the medial and/or posterior malleolar fractures) are then performed.

13

Optional: Independent Lag Screw Technique

Operative Technique

A 3.5mm VariAx Foot and Ankle Non-Locking Screw can be used as an independent lag screw to reduce fibula fractures, prior to fixation using a VariAx Fibula plate. The VariAx Foot and Ankle instrumentation system includes a Drill Guide for a 3.5mm Independent Lag Screw (45-80003), which is designed to only be used when drilling and overdrilling a hole for independent lag screw fixation using a 3.5mm screw. Thistechniquemustnotbeperformedthroughaplate.

The procedure for preparing a hole for independent lag screw insertion is as follows:

1. Anatomic reduction is achieved and maintained with a pointed reduction clamp.

2. Identify the appropriate drill guide. For 3.5mm screws, use the Drill Guide for 3.5mm Independent Lag Screws (45-80003). This drill guide has two sides/sleeves. Identify the side labeled “Near Fragment”, which is also color-coded. For 3.5mm independent lag screw fixation, the near fragment side of the appropriate drill guide will have yellow and red lines on the drill sleeve, and a red “window”.

3. The correct overdrill is directly placed against bone for drilling the near fragment. For 3.5mm screws, use the overdrill that is color-coded with a red and yellow line. (45-35020).

4. The red and yellow color-coded drill bit is then inserted through the identical red and yellow drill guide, and drilling is performed completely through the near fragment to create a gliding hole. This drilling must completely pass through the near fragment, and into the interfragmentary space, otherwise lagging of the far fragment will not be possible.

14

5. The other side of the drill guide, which is yellow color-coded, is then fully inserted into the newly created gliding hole. For 3.5mm screws, the drill sleeve will have a yellow color-coding. This drill guide must be inserted as deep as possible into the overdrilled hole. The appropriate yellow color-coded 2.6mm drill (45-35010) is then chosen. Drilling is performed using the appropriate drill, into the far fragment. The end result of the drilling process will be a co-linear hole through the near fragment, and into the far fragment, where the diameter of the hole in the near fragment will be bigger than the diameter of the hole in the far fragment (thus allowing for lagging).

6. When appropriate, use the countersink (45-80040) to minimize screw head prominence and reduce stress riser effects to the bone during final screw tightening.

7. Screw length is then measured using the Depth Gauge for 3.5mm screws (45-35001).

8. The screw can then be inserted. A washer (40-35900) could also be used if necessary due to bone quality. If a washer is intended to be used the countersink should not be applied before.

Operative Technique

15

Operative Technique

Optional: Syndesmotic Screw Fixation Technique• After completion of all fixation, an intra-operative Cotton test or external rotation stress test is performed under fluoroscopy and syndesmotic reduction and fixation is performed as needed.

- A stab incision is made medially near the metaphysis.

- A large peri-articular clamp is used to obtain and maintain an anatomic syndesmotic reduction which should be confirmed fluoroscopically on the A/P, mor-tise, lateral view by inspection or palpation via the surgical expo-sure. Using the drill guide the 2.6mm yellow color-coded drill bit is used to make a pilot hole paral-lel to the tibio-talar articulation and the trans-malleolar axis. Care must be taken to avoid excessive angu-lation through the plate beyond 15°.

• One or two tri-cortical or tetra-cortical 3.5mm non-locking screws can be used to achieve syndesmotic fixation based on patient factors, injury factors, and surgeon preference.

For Bi Malleolar Fractures

Asnis III

4mm 5mm

16

Ordering Information - Implants

3.5mm LOCKING SCREWS REF Description Description

40-35610 (S) Locking Screw, T10, 3.5 × 10mm 40-35612 (S) Locking Screw, T10, 3.5 × 12mm 40-35614 (S) Locking Screw, T10, 3.5 × 14mm 40-35616 (S) Locking Screw, T10, 3.5 × 16mm 40-35618 (S) Locking Screw, T10, 3.5 × 18mm 40-35620 (S) Locking Screw, T10, 3.5 × 20mm 40-35622 (S) Locking Screw, T10, 3.5 × 22mm 40-35624 (S) Locking Screw, T10, 3.5 × 24mm 40-35626 (S) Locking Screw, T10, 3.5 × 26mm 40-35628 (S) Locking Screw, T10, 3.5 × 28mm 40-35630 (S) Locking Screw, T10, 3.5 × 30mm 40-35632 (S) Locking Screw, T10, 3.5 × 32mm 40-35634 (S) Locking Screw, T10, 3.5 × 34mm 40-35636 (S) Locking Screw, T10, 3.5 × 36mm 40-35638 (S) Locking Screw, T10, 3.5 × 38mm 40-35640 (S) Locking Screw, T10, 3.5 × 40mm 40-35642 (S) Locking Screw, T10, 3.5 × 42mm 40-35644 (S) Locking Screw, T10, 3.5 × 44mm 40-35646 (S) Locking Screw, T10, 3.5 × 46mm 40-35648 (S) Locking Screw, T10, 3.5 × 48mm 40-35650 (S) Locking Screw, T10, 3.5 × 50mm 40-35655 (S) Locking Screw, T10, 3.5 × 55mm 40-35660 (S) Locking Screw, T10, 3.5 × 60mm 40-35665 (S) Locking Screw, T10, 3.5 × 65mm 40-35670 (S) Locking Screw, T10, 3.5 × 70mm

3.5mm NON-LOCKING SCREWS REF Description 40-35010 (S) Bone Screw, T10, 3.5 × 10mm 40-35012 (S) Bone Screw, T10, 3.5 × 12mm 40-35014 (S) Bone Screw, T10, 3.5 × 14mm 40-35016 (S) Bone Screw, T10, 3.5 × 16mm 40-35018 (S) Bone Screw, T10, 3.5 × 18mm 40-35020 (S) Bone Screw, T10, 3.5 × 20mm 40-35022 (S) Bone Screw, T10, 3.5 × 22mm 40-35024 (S) Bone Screw, T10, 3.5 × 24mm 40-35026 (S) Bone Screw, T10, 3.5 × 26mm 40-35028 (S) Bone Screw, T10, 3.5 × 28mm 40-35030 (S) Bone Screw, T10, 3.5 × 30mm 40-35032 (S) Bone Screw, T10, 3.5 × 32mm 40-35034 (S) Bone Screw, T10, 3.5 × 34mm 40-35036 (S) Bone Screw, T10, 3.5 × 36mm 40-35038 (S) Bone Screw, T10, 3.5 × 38mm 40-35040 (S) Bone Screw, T10, 3.5 × 40mm 40-35042 (S) Bone Screw, T10, 3.5 × 42mm 40-35044 (S) Bone Screw, T10, 3.5 × 44mm 40-35046 (S) Bone Screw, T10, 3.5 × 46mm 40-35048 (S) Bone Screw, T10, 3.5 × 48mm 40-35050 (S) Bone Screw, T10, 3.5 × 50mm 40-35055 (S) Bone Screw, T10, 3.5 × 55mm 40-35060 (S) Bone Screw, T10, 3.5 × 60mm 40-35065 (S) Bone Screw, T10, 3.5 × 65mm 40-35070 (S) Bone Screw, T10, 3.5 × 70mm

17


PLATES

Plate Specifications mm

Thickness Shaft 2.0Distal End 1.3Width Shaft 10Width Distal End 16 * Please add “S” to the article number (REF) for sterile

packed product.

Length REF Description mm

40-20903 (S) VariAx Fibula Plate, 3 holes 77







40-20910S VariAx Fibula Plate, 10 holes 161

40-20912S VariAx Fibula Plate, 12 holes 185

REF Description

Trials

40-20903T Distal Lateral Fibula Trial, 3 holes 40-20905T Distal Lateral Fibula Trial, 5 holes 40-20907T Distal Lateral Fibula Trial, 7 holes 40-20909T Distal Lateral Fibula Trial, 9 holes 40-20912T Distal Lateral Fibula Trial, 12 holes

18


REF Description

40-35900 (S) Washer for 3.5mm Screw

REF Description 45-80100(S) K-Wire, Fully Threaded, 1.6mm × 200mm

45-80200(S) K-Wire, Smooth, 1.4mm × 100mm

WASHERS*

K-WIRES & STEINMANN PINS

* Please add “S” to the article number (REF) for sterile packed product.

19

Ordering Information - Instruments

REF Description

Instruments

45-35010(S) Drill, 2.6mm x 122mm, WL70mm, AO-Shaft

45-35005(S) Tap for 3.5mm Screws, AO, 70mm

45-35001 Depth Measuring Gauge for 3.5mm Screws

45-80001 Drill Guide for Circular Locking Holes

45-35015 Screwdriver Blade, AO, T10

45-85000 Screwdriver Handle, Revolving/Rigid, AO

45-35030 Holding Sleeve for 3.5mm Screws

45-80010 Plate Bending Pliers

45-80020 K-Wire Cutting Pliers (max 1.6mm)

64-20129 Forceps with Grasping Lips

DistalFibulaAdditionalInstruments

45-35020(S) Overdrill for 3.5mm Screws, AO Fitting

45-80040(S) Countersink for Screws ø2.7/3.5mm, AO Fitting

45-80003 Drill Guide for 3.5mm Independent Lag Screw

20


REF Description

OptionalInstruments

45-80030 Joint Distraction Forceps

45-80300(S) Steinmann Pin, Smooth, 2.5mm x 100mm

45-90001 X-Ray Template

702926 Repositioning Forceps with Points

702932 Repositioning Forceps with Serrated Jaws

702944 Repositioning Forceps with Ballspike

702936 Mantis Tongs Forceps - King

700151 Hook

700664 Hohmann Retractor 6mm 700665 Hohmann Retractor 8mm 700667 Hohmann Retractor 15mm

45-35002 VariAx Depth Gauge for 2.7/3.5mm Screws, Black

21


REF Description

Screwmarkers

52-00010 Screw Length Marker for 10mm

























22

Ordering Information - Cases & Trays

REF Description

ModulesAndTrays

29-35000 Sterilization Container, 3 levels

29-13009 Sterilization Container, 4 levels

29-35200 Stryker Foot Container Lid - Half Size

29-31400 VariAx Foot Instrument Tray

29-31460 Instrument/Accessory Tray

29-31008 Customizable Screw Rack without Markers

29-31009 Screw Rack with Markers**

29-31004 Screw Rack for 3.5 Locking Screws

29-31005 Screw Rack for 3.5 Bone Screws

29-31001 VariAx Distal Fibula Plate Module incl. Lid

29-50000 Generic Inlay

29-31007 Drawer for Screw Racks

29-13462 Accessory Tray

29-31014 Lid for VariAx Distal Fibula Plate Module (spare part)

Note:**Pre-configuredscrewrack(29-31009)forVariAxFibulaLockingPlateSystemfor3.5mmLocking

andNon-Lockingscrewlengths10mm-28mm.

23

Stryker Leibinger GmbH & Co. KGBötzinger Straße 41D-79111 FreiburgGermany

www.osteosynthesis.stryker.com

Thisdocumentisintendedsolelyfortheuseofhealthcareprofessionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any par-ticular product before using it in surgery. The information presented in this brochure is intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions including the instructions for Cleaning and Sterilization (if applicable) before using any Stryker products. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Stryker, SmartLock and VariAx. All other trademarks are trademarks of their respective owners or holders.

The products listed above are CE marked.

Literature Number : 90-07810LOT D3410

Copyright © 2010 Stryker

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