FIBULINK®

Syndesmosis Repair SystemSurgical Technique

FIBULINKFIBULINK®

Syndesmosis Syndesmosis Repair SystemRepair SystemSurgical TechniqueSurgical Technique

Introduction

Surgical Technique

Product Information

Image intensifier control

Table of Contents

FIBULINK® Syndesmosis Repair System Surgical Technique DePuy Synthes 1

FIBULINK® Syndesmosis Repair System 2

Indications, Contraindications, and 3 MRI Safety Information

FIBULINK Implant Kit Components 4

Implant Site Preparation 5

Tibia Screw Insertion 7

Tibia Screwdriver Removal 10

Fibula Tensioning Cap Installation 11

FIBULINK Removal Kit Components 14

Removal (Optional) 15

Features of the FIBULINK Syndesmosis Repair System 18

Implants and Kits 19

Additionally Available 19

2 DePuy Synthes FIBULINK® Syndesmosis Repair System Surgical Technique

FIBULINK® Syndesmosis Repair System

The DePuy Synthes FIBULINK® Syndesmosis Repair System is a novel implant solution providing the fi xation of a screw and the fl exibility of a suture. It is designed to enable precise, anatomic syndesmotic fi xation.1,2 The FIBULINK System’s fl exible suture bridge eliminates the risk of complications and removal surgeries associated with broken syndesmotic screws.3 In addition, it addresses limitations of suture button constructs including medial soft tissue disruption and lack of two-way tension control.*1,4

Improves Tension ControlTension can be fi ne-tuned and readjusted intraoperatively with the turn of a knob*1,4

Eliminates Medial DisruptionNo medial incision or hardware, which eliminates medial side complications and helps improve procedural effi ciency*1

Enables Physiologic MotionShort, high-strength suture bridge is designed to enable physiologic ankle motion1,4

The FIBULINK System is compatible with the DePuy Synthes fi bula plating line and is available in stainless steel and titanium.†5 It is provided in sterile kits with the required implants and instrumentation.

*Compared to suture button constructs.†See page 18 for compatibility detail.

FIBULINK® Syndesmosis Repair System Surgical Technique DePuy Synthes 3

Indications, Contraindications, and MRI Safety Information

Indications for UseThe FIBULINK Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the FIBULINK Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

ContraindicationsUse of the FIBULINK Syndesmosis Repair Kit is contraindicated in the presence of an acute local infection.

MRI Safety Information

Non-clinical testing has demonstrated the FIBULINK implant is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions: • Static magnetic field of 1.5 T and 3.0 T • Maximum spatial field gradient of 1,900 gauss/cm (15 T/m) • Maximum MR system reported, whole body averaged

specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the FIBULINK implant is expected to produce a maximum temperature rise of 1.7º C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 15 mm from this implant when imaged with a gradient echo pulse sequence and a 3.0 T MRI system.

4 DePuy Synthes FIBULINK® Syndesmosis Repair System Surgical Technique

FIBULINK Implant Kit Components

1.4 mm K-wire

3 mm/4 mm Step-drill Bit

Tibia Screwdriver and Implant Assembly

Washer Long Tensioning Cap

Tensioning Knob and Standard Tensioning Cap

FIBULINK® Syndesmosis Repair System Surgical Technique DePuy Synthes 5

Surgical TechniqueImplant Site Preparation

1. Implant Site Preparation

If required, fi xate the fi bular fracture using a FIBULINK System compatible device and routine AO principles. Verify that the fi bula can be reduced to the tibia with congruent tibiofi bular joint articulation. The K-wire must be placed while the tibiofi bular joint is reduced; otherwise, tightening will progressively subluxate the joint.

Insert the K-wire through the fi bula and into the tibia approximately 2 cm above the plafond. The K-wire must be centered in the hole of the plate to ensure that the plate will not be damaged by the drill. The K-wire must be inserted at 20-30° of anterior deviation to accommo-date the tibiofi bular syntopy. Placement should be verifi ed under fl uoroscopy.

6 DePuy Synthes FIBULINK® Syndesmosis Repair System Surgical Technique

Drill with the provided step-drill over the K-wire to prepare a 3 mm pilot hole in the tibia and a 4 mm gliding hole in the fi bula. If desired, the step-drill can be performed by hand with a hand driver. Care should be taken to ensure that the step in the drill exits the medial cortex of the fi bula, but does not enter the lateral cortex of the tibia. Drill step location should be checked with fl uoroscopy during the drilling process.

Surgical TechniqueImplant Site Preparation

X

P

Withdraw the K-wire and step-drill, leaving the pilot hole in the tibia and the gliding hole through the fi bula.

Correct Depth

Too Deep

FIBULINK® Syndesmosis Repair System Surgical Technique DePuy Synthes 7

2. Tibia Screw Insertion

Using its preloaded screwdriver, insert the tibia screw through the gliding hole in the fi bula until it comes into contact with the pilot hole previously drilled in the tibia.

Surgical Technique

Tibia Screw Insertion

1 DePuy Synthes FIBULINK® Syndesmosis Repair System Surgical Technique

Drive the tibia screw into the tibia using clockwise rotation of the driver. A sharp increase in the torque indicates that the shoulder of the driver has contacted the lateral cortex of the tibia and that the tibia screw installation is complete. Proper fl ush placement of the tibia screw in the tibia should be verifi ed under fl uoroscopy.

Surgical TechniqueTibia Screw Insertion

P

X

X

Correct Depth

Too Deep

Too Proud

FIBULINK® Syndesmosis Repair System Surgical Technique DePuy Synthes 9

With the syndesmosis reduced, note the indicator groove on the driver shaft.

Standard Tensioning Cap Long Tensioning Cap

If it remains visible when the tibia screw is fully installed, then the standard tensioning cap should be used. If the indicator groove goes below the surface of the fi bula or the fi bular plate, then the long tensioning cap should be used.

Surgical TechniqueTibia Screw Insertion

10 DePuy Synthes FIBULINK® Syndesmosis Repair System Surgical Technique

3. Tibia Screwdriver Removal

Release the suture from the driver handle by pulling laterally on the tag end of the suture.

Once the suture is unwound, let go of the suture and pull the driver handle out laterally, pulling the suture through the handle. This exposes the guide tube, which is used to control the fi bula link and guide installation of the fi bula tensioning cap.

Surgical Technique

Tibia Screwdriver Removal

Fibula Link

FIBULINK® Syndesmosis Repair System Surgical Technique DePuy Synthes 11

4. Fibula Tensioning Cap Installation

Ensure that the appropriate tensioning cap is snapped onto the tensioning knob (refer to step #2; remove standard cap and replace with long version, if required) and then slide it over the guide tube and into the gliding hole in the fi bula.

In treatment of a syndesmotic disruption in which an interfacing fi xation plate is not present, the recommended technique is to use the FIBULINK Implant in conjunction with the supplied washer. The washer should be placed over the guide tubes prior to tensioning cap installation.

A clamp or hemostat should then be clamped to the silver portion of the guide tube (not the gold-colored most proximal portion). The purpose of this is to keep the link aligned and prevent suture winding.

Surgical Technique

Fibula Tensioning Cap Installation

X

P

12 DePuy Synthes FIBULINK® Syndesmosis Repair System Surgical Technique

Pulling laterally on the silver guide tube engages the external threads of the link with the internal threads of the tensioning cap.

With the preliminary reduction maintained, clockwise rotation of the tensioning knob advances the tensioning cap and increases the tension of the FIBULINK Implant. If the surgeon desires, the ankle may be placed in dorsifl exion prior to increasing tension of the FIBULINK Implant.

The tensioning cap is advanced until the desired level of correction is achieved, which must be confi rmed by standard radiography.

To decrease tension of the FIBULINK, the tensioning knob is turned counterclockwise while still holding the guide tube with the clamp. This fi ne-tuning allows the surgeon to dial in the correction of the syndesmotic injury. Flouroscopy, direct inspection, and ankle range of motion can then be used to ensure an anatomic reduction. Fine-tuning can be performed by increasing and decreasing tension of the FIBULINK as described above if desired.

Note: An over-torque indicator is built into the tensioning knob. This limiter is present to prevent the surgeon tightening beyond the point at which the construct might fail.

Surgical TechniqueFibula Tensioning Cap Installation

Before Lateral Pull

After Lateral Pull

FIBULINK® Syndesmosis Repair System Surgical Technique DePuy Synthes 13

Surgical TechniqueFibula Tensioning Cap Installation

Once the surgeon is satisfi ed with the correction, the the guide tube is unclamped. The clamp is then used to pull the gold-colored proximal portion of the guide tube laterally, which releases the guide tube assembly from the implant and allows for removal of the silver guide tube.

The tensioning knob is then unsnapped from the tensioning cap.

Implant installation is complete.

Remove gold fi rst, silver second

14 DePuy Synthes FIBULINK® Syndesmosis Repair System Surgical Technique

Surgical Technique

FIBULINK Removal Kit Components

Fibula Link and Tibia Screw Remover

Tibia Screw Remover

Fibula Tensioning Cap Remover

Instruments have male or female hexalobe interfaces to correspond to mating FIBULINK Implant components.

FIBULINK® Syndesmosis Repair System Surgical Technique DePuy Synthes 15

Surgical Technique

Removal (Optional)

5. Removal (Optional)

Removal of the implant is completed by reversing installation steps. The dedicated removal kit should be used for FIBULINK Implant removals.

Note: The Tensioning Cap Remover from the FIBULINK Removal Kit is not compatible with implants implanted prior to July 2020. If an implant removal is required, please use the kit as well as a commercially available T20 screwdriver or Conical Extraction Screw (309.520) from the DePuy Synthes Screw Removal Set (01.240.001) to remove the tensioning cap.

5.1 Insert the Tensioning Cap Remover into the tensioning cap and turn counterclockwise to remove the cap.

5.2 There are two likely outcomes of cap removal depending on the condition of the implant at the time of removal. • The suture connecting the link and tibia screw

remains intact and the cap is spun counterclockwise off the link. (see step 5.2.A)

• The link and the tibia screw are no longer connectedand rotation of the cap does not separate it from the link. Both the link and cap can then be pulled laterally to remove as a unit. (see step 5.2.B)

16 DePuy Synthes FIBULINK® Syndesmosis Repair System Surgical Technique

5.2 A. Cap Removed Only. If the suture, link, and tibia screw remain intact, then the Fibula Link and Tibia Screw Remover should be used, which is the same instrument as the tibia screwdriver for installation. The female distal end of the driver must fi rst capture the link. With the link captured, advance the driver and link into the female hexalobe in the proximal portion of the tibia screw. The distal end of the link is a male hexalobe matching the female hexalobe tibial screw. With the link engaged with the tibia screw, the tibia screw may be reversed out of the tibia and fi bula.

Surgical TechniqueRemoval (Optional)

FIBULINK® Syndesmosis Repair System Surgical Technique DePuy Synthes 17

5.2.B Cap and Link Both Removed. If the cap and link are retrieved together, then the Tibia Screw Remover (a hexalobe retrieval driver) should be used to engage with the female hexalobe in the proximal portion of the tibia screw. Once the Tibia Screw Remover engages with the tibia screw, reverse thread the tibia screw out of the tibia through the initial implant site.

Surgical TechniqueRemoval (Optional)

11 DePuy Synthes FIBULINK® Syndesmosis Repair System Surgical Technique

(1) Fibula Tensioning Cap• Two cap options: Standard (10 mm) and Long (15 mm)• Standard cap is preloaded onto the Tensioning Knob• Interfaces with the fibula link; rotation of cap applies

tension to the construct

(2) Fibula Link• 2.8 mm Outer Diameter; 10.7 mm length• 40 external threads per inch• Connects suture bridge to tensioning cap; interface

is the primary tension mechanism

Features of the FIBULINK Syndesmosis Repair System

CompatibilityThe 4 mm FIBULINK Implant is compatible with any distal fibula plate hole which accepts a 4 mm non-locking cortex screw. Additionally, various 3.5 mm screw holes may accommodate the FIBULINK Implant but compatibility must be verified. Within the DePuy Synthes distal fibula plate family, the FIBULINK Implant is compatible with• Non-locking 1/3 Tubular Plate holes• The non-threaded portion of a combi hole in a 3.5 mm

locking plate (LCP® Plates)• Syndesmotic slot (VA LCP® Plates)5

(1) Fibula Tensioning Cap (3) PERMACORD® Suture Bridge

(2) Fibula Link (4) Tibia screw

(3) PERMACORD® Suture Bridge• 4 strands of #1 PERMACORD® Suture (UHMWPE),

crossing 4 mm gap between anchors• Provides compression between the fibula and tibia

components

(4) Tibia screw• Unicortical, 22 mm in length• 4 mm cortical threadform, transitioning to 4 mm

cancellous towards the distal tip• Functions as an anchor in the tibia

FIBULINK® Syndesmosis Repair System Surgical Technique DePuy Synthes 19

Sterile Implant KitsFGS-1000 FIBULINK® Syndesmosis Repair Kit,

Stainless Steel

FGS-1100 FIBULINK® Syndesmosis Repair Kit, Titanium

Sterile Instrument KitsFGS-1300 FIBULINK® Removal Kit

Implants and Kits

Additionally Available03.118.001 Periarticular Reduction Forceps, Small

03.118.110 Periarticular Reduction Forceps, Medium

© DePuy Synthes 2020. All rights reserved.AS ST 001 R02 06/20 DV

Manufactured by:Akros Medical An Affiliate of DePuy SynthesEimattstrasse 34436 OberdorfSwitzerland

To order (USA): 800-523-0322 To order (Canada): 844-243-4321

www.jnjmedicaldevices.com

Distributed by:Synthes USA, LLC 1101 Synthes AvenueMonument, CO 80132

Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information.

CAUTION: Federal Law restricts these devices to sale by or on the order of a physician.

Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada.

Not all products may currently be available in all markets.

References1. DePuy Synthes. Syndesmosis Physiologic Motion & Soft Tissue Rationale. 2020. 2. DePuy Synthes. FIBULINK Indications Memo, #0000295747. 2020. 3 Laflamme M, Belzile EL, Bedard L, van den Bekerom MP, Glazebrook M, Pelet S. A prospective randomized multicenter trial comparing clinical

outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture. J Orthop Trauma. 2015;29(5):216-223.4. DePuy Synthes. FIBULINK Competitive Evaluation Memo. 2020. 5. DePuy Synthes. FIBULINK Plate Compatibility Memo, #0000295062. 2020.