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VariAx
Operative Technique
Distal Fibula Fracture Repair Polyaxial Locking Technology Low Profile Design
VariAx Fibula
Contributing Surgeon
Bradley R. Merk, MD Associate Professor of Orthopaedic Surgery Director of Orthopaedic Trauma Feinberg School of Medicine Northwestern University Chicago, USA
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: Fixation Screws: Stryker Ostreosynthesis bone screws are not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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Table of Contents
1. 2. 3. Introduction Features & Benefits Overview Plate Options Screw Options 4. 5. Indications, Precautions & Contraindications Operative Technique Planning and Preparation Preparation for Screw Insertion Screw Insertion Final Steps Optional: Independent Lag Screw Technique Optional: Syndesmotic Screw Fixation Technique Ordering Information - Implants Ordering Information - Instruments Ordering Information - Cases & Trays Page 4 5 6 6 6 7 8 8 10 13 13 14 16 17 20 23
Introduction
The VariAx Fibula Locking Plate System represents a new generation of implant technology The reconstruction and fixation of distal fibular fractures can now be enhanced by means of the patented SmartLock polyaxial locking 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.
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Patented Polyaxial Locking Technology 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-Step Locking Achieved by simply inserting a locking screw within the polyaxial locking range of 15, without the need for further steps.
Modular System Design The modular instrumentation system is designed for seamless integration of other products from the Stryker Foot portfolio.
Color-Coding of Instruments 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.
Pre-contoured Periarticular Plate Design 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*. Low Profile Plate Design and Reduced Screw Head Prominence 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-Wire Holes in the Plate To allow for temporary fixation in order to ease plate application. A Clustering of Distal Screws Allows for multiple points of fixation to treat comminuted fractures or fractures with limited distal bone stock.
Full-Range of 3.5mm Locking and Non-Locking Screws Offers intra-operative solutions to cover a broad range of clinical situations. Polyaxial Drill Guide Allows placement of locking screws at a variable angle (up to 15). Efficient T10 Screw Head Design All 3.5mm VariAx Fibula Locking Plate screws are designed with a T10 head. This screw head design facilitates efficient force transmission from the screwdriver blade to the screw, and helps reduce the risk of screw head stripping. Anodization Type II Optional Independent Lag Screw Fixation A full range of non-locking VariAx screws are available for placement of independent lag screws.
Fibula Plate
Screw Options
3.5mm NonLocking
3.5mm Locking
Weber A, B, C fractures of the distal fibula with and without syndesmotic injury. Distal Fibula non-unions and malunions.
Contraindications
The following contraindications may be of a relative or absolute nature, and must be taken into account by the attending surgeon: Inadequate bone quantity and quality. 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.
Operative Technique
The Operative Technique listed below is designed to provide a general overview on the instruments and procedure required to implant a VariAx 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: Excessive plate bending may lead to failure of the locking mechanism and should be avoided.
Operative Technique
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.
Note: Drill guides should always fit securely within a screw hole a mis-match between the drill guide and the plate hole indicates that the wrong dimension drill guide has been chosen.
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Operative Technique
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 the respective plate hole prior to measuring. Measuring without a plate will result in a false reading.
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Operative Technique
Assemble the appropriate Screwdriver Blade (with AO fitting) with the Screwdriver Handle, Revolving/Rigid, AO (45-85000). Please note: Only the yellow color-coded Screwdriver Blade, AO, T10 (45-35015) is used to insert 3.5mm screws. Begin by pushing the AO quickconnect sleeve towards the body of the Screwdriver Handle, insert the screwdriver blade into the AO quick-connect coupling, and then release the sleeve.
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 holding sleeve and slide it over the screwdriver until it engages, as shown.
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.
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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.
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Operative Technique
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.
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77
89
101
113
125
137
149
40-20910S
161
40-20912S
185
Description
Distal Lateral Fibula Trial, 3 holes Distal Lateral Fibula Trial, 5 holes Distal Lateral Fibula Trial, 7 holes Distal Lateral Fibula Trial, 9 holes Distal Lateral Fibula Trial, 12 holes
Plate Specifications Thickness Shaft Distal End Width Shaft Width Distal End
mm 2.0 1.3 10 16
* Please add S to the article number (REF) for sterile packed product.
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* Please add S to the article number (REF) for sterile packed product.
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Instruments 45-35010(S) 45-35005(S) 45-35001 45-80001 45-35015 Drill, 2.6mm x 122mm, WL70mm, AO-Shaft Tap for 3.5mm Screws, AO, 70mm Depth Measuring Gauge for 3.5mm Screws Drill Guide for Circular Locking Holes Screwdriver Blade, AO, T10
45-85000
45-35030
45-80010
45-80020
64-20129
Distal Fibula Additional Instruments 45-35020(S) 45-80040(S) 45-80003 Overdrill for 3.5mm Screws, AO Fitting Countersink for Screws 2.7/3.5mm, AO Fitting Drill Guide for 3.5mm Independent Lag Screw
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Steinmann Pin, Smooth, 2.5mm x 100mm X-Ray Template Repositioning Forceps with Points
702932
702944
702936
Hook Hohmann Retractor 6mm Hohmann Retractor 8mm Hohmann Retractor 15mm VariAx Depth Gauge for 2.7/3.5mm Screws, Black
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29-13009
29-35200
29-31400
29-31460
Instrument/Accessory Tray
29-31008
29-31009
29-31004
29-31005
29-31001
29-50000
Generic Inlay
29-31007
29-13462
Accessory Tray
29-31014
Note: ** re-configured screw rack (29-31009) for VariAx Fibula Locking Plate System for 3.5mm Locking P and Non-Locking screw lengths 10mm - 28mm.
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Stryker Leibinger GmbH & Co. KG Btzinger Strae 41 D-79111 Freiburg Germany www.osteosynthesis.stryker.com
This document is intended solely for the use of healthcare professionals. 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 particular 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 : 90-07810 LOT D3410 Copyright 2010 Stryker