Finished Product

FIB30130L

Foot and Ankle

Product

The FibuLock fibular nail is a cutting-edge, minimally invasive treatment for ankle fractures. It is inserted into the fibula through a minimal incision and acts like an internal splint to stabilize the fracture during healing. This minimally invasive technique may reduce wound complications often associated with standard open reduction internal fixation plating techniques.1 The proximal “talons” allow for stable fixation to restore length, alignment, and rotation. The FibuLock nail is the only system on the market with this capability.
Reference:
1. Foot and Ankle International. 2016;37(1):115-123. doi:1177/1071100715622392.

FibuLock® Fibular Nail

Child (D)

Procedure

The FibuLock nail is a cutting-edge, minimally invasive treatment for ankle fractures. It is inserted into the bone through a minimal incision and acts like an internal splint to stabilize the fracture during healing. The proximal “talons” allow for stable fixation to restore length, alignment, and rotation. The Fibulock nail is the only system on the market with this capability.

The FibuLock® fibular nail addresses ankle fractures using a minimally invasive technique that may reduce the risk of wound complications associated with ORIF.1 The innovative proximal talons and distal multiplanar 2.7 mm screws work to maintain length, alignment, and rotation of the fracture. Syndesmosis injuries can be treated through the nail with the Syndesmosis TightRope® XP implant.
1. Walton DM, Adams SB, Parekh SG. Intramedullary fixation for fractures of the distal fibula. Foot Ankle Int. 2016;37(1):115‐123. doi: 10.1177/1071100715622392

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FibuLock® Fibular Nail Surgical Technique

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FibuLock Fibular Nail System ® Surgical Technique Arthrex FibuLock® Fibular Nail Talons: Provide proximal fixation May be easily deactivated for removal Specifications: 3.0 mm and 3.8 mm diameters 130 mm and 180 mm lengths 316L stainless steel Syndesmosis Fixation: Accepts the Syndesmosis TightRope® XP implant or 3.5 mm syndesmotic screws Multiplanar Screws: 2.7 mm cortical locking 2 lateral/medial screws 1 anterior/posterior screw Compression Slot: Allows 2.5 mm of compression Optional End Cap: Locks in compression 02 I Introduction Prevents bone ingrowth Introduction Operative fixation of an ankle fracture requires restoration of appropriate length, alignment, and restoration of a stable ankle mortise. The FibuLock® fibular nail system was designed to fulfill those operative objectives, while using a soft-tissue–friendly, minimally invasive approach for fibula fractures. The FibuLock fibular nail can be used for both proximal and distal fixation along with syndesmotic fixation, which can be achieved using our TightRope® implant technology. Multiplanar distal fixation allows for treatment of almost any ankle fracture. The nail insertion outrigger can provide compression if needed and ensure syndesmosis fixation is parallel to the mortise with either 3.5 mm screws or the TightRope implant system angled posterior to anterior. Introduction I 03 FibuLock ® Fibular Nail System—Preoperative Planning Evaluation of the proximal canal size can help when selecting the proper nail diameter. Determine if the isthmus or canal is large enough to accept a 3.2 mm reamer. Basic AP and lateral radiographic landmarks (isthmus and fibular fossa) of the distal fibula will aid in entry point accuracy and ensure the guidewire is in the center of the canal. Isthmus Malleolar fossa Correct entry point—lateral to the edge of the malleolar fossa Patient Positioning 04 I Preoperative Planning Entry Point 1 Make a small skin incision 1 cm distal to the tip of the fibula, down the axis of the fibula. When reducing the fracture, place clamp handles proximally to avoid outrigger interference. Many reductions are percutaneous, but older fractures may require a limited open approach for anatomic reduction. 2 Entry Point and Initial Guidewire Trajectory: Establish the entry point using the 1.6 mm guidewire and tissue protector. Advance the guidewire 15 mm to 20 mm into the distal fibula with the drill on oscillate. Supinating the foot will increase accessibility to the distal fibula. Starting Point AP: Lateral to the edge of the malleolar fossa Lateral: In line with the center of the canal 3 Take multiple AP and lateral fluoroscopy views to ensure the guidewire is angled towards the center of the canal. Note: Avoid placing the guidewire too lateral as reaming will violate the lateral cortex of the fibula. Once a good entry point and trajectory are established, advance the guidewire further into the fibula. Entry Point and Starting Point I 05 Distal Reaming 4 Drive the 6.2 mm tapered reamer over the guidewire through the tissue protector until the reamer flutes are fully within the bone. However, if there is adequate room, burying the flutes at least 3 mm can be advantagous. The reamer shaft features a secondary depth indicator correlating to the back of the tissue protector. Proximal Reaming 5 Drive the 3.2 mm reamer over the guidewire and through the tissue protector, until the depth indicator collar is well within the bone. If chatter is not evident, repeat with the 4.0 mm reamer. Reamer placement should be checked in two planes to avoid cortical disruption. Use the corresponding long reamers for 180 mm nails when indicated. Ream on oscillate and recheck the reduction after this step. Attach the appropriate nail (diameter and length) to the outrigger. Note: 3.2 mm reamer = 3.0 mm nail, 4.0 mm reamer = 3.8 mm nail. 06 I Distal Reaming and Proximal Reaming Outrigger Nail Assembly Nail shaft angles up toward the outrigger 6 Outrigger Attachment Screw Torque-Limiting Actuation Driver 7 Impactor Cap Remove the guidewire. Insert the nail with the outrigger directly lateral to the leg. A mallet should not be required. Outrigger Nail Assembly I 07 FibuLock ® Fibular Nail System 8a 8b After the nail is inserted and before the talons are activated, confirm the position of the nail on fluoroscopy (8b). Place a 1.6 mm K-wire in the outrigger “end hole” to confirm that the distal portion of the nail (blue circle) is flush or countersunk in the fibula. 9 Actuate the Talons Confirm the outrigger is positioned lateral prior to actuation. Remove the impactor cap. Insert the actuation driver. Hold the outrigger while actuating to prevent rotation. Turn the actuation driver until it “clicks” to deploy the talons. The talons may not deploy fully in a tight canal. Do not rotate the nail after talon actuation. K-wires can be placed through the outrigger to control rotation provisionally. 3 mm nail talons expand to 5 mm 3.8 mm nail talons expand to 6 mm 08 I FibuLock Fibular Nail System 2.7 mm Distal Screw Fixation 2.0 mm Drill Drill Guide Drill Guide Sleeve Drill Guide Sleeve Screw Driver 10 Ensure the outrigger slide is in the “static” position. Insert the drill guide sleeve and 2 mm drill guide into a 2.7 mm hole in the outrigger. The proximal lateral to medial hole is the most commonly used. Drill, measure, and insert the appropriate 2.7 mm screw through the drill guide sleeve. Repeat in the other lateral to medial hole and the anterior to posterior hole as needed. Syndesmotic Fixation TightRope® Implant 3.5 mm Screw Drill Guide Sleeve Drill Guide Sleeve 3.7 mm Syndesmotic Drill Guide (black) 2.5 mm Syndesmotic Drill Guide (gold) 3.7 mm Drill Bit 2.5 mm Drill Bit TightRope XP Implant 3.5 mm Syndesmotic Screw 11 Drill all four cortices approximately 1.5 cm from the ankle joint, in the transmalleolar plane through the jig, using the 3.7 mm drill bit. 2.7 mm Distal Screw Fixation and Syndesmosis Fixation I 09 FibuLock ® Fibular Nail System 12 13 Check under fluoroscopy to ensure the medial button exits the medial tibia cortex. Advance the Syndesmosis TightRope® XP implant system through the fibula and tibia bone tunnel. Position the black button on the blue handle inserter cephalad or caudad. 14 Remove the red safety tab. Deploy the medial button on the Syndesmosis TightRope XP handle by engaging the black button away from the TightRope construct. 15 Insert the End Cap Insert a 1.35 mm K-wire into the nail end. Screw the end cap over the K-wire into the nail using the cannulated T15 driver. 10 I FibuLock Fibular Nail System Final fixation. Important: After deploying the medial button, push the Syndesmosis TightRope XP implant medially. Visualize a T shape on fluoroscopy. Once the position of the medial button has been confirmed, remove the TightRope sutures and lateral button from the blue handle, then tension appropriately. Optional Steps—Entry Point If the guidewire is malpositioned, the guidewire offset guide can be used to redrill a new guidewire 2.5 mm or 5 mm from the initial guidewire. Optional Steps—Fracture Finger Technique If there is difficulty getting the guidewire past the fracture or the guidewire keeps getting caught on the medial corte, the fracture finger technique can be used to insert the guidewire proximally in the fibular canal. Fracture Finger 1 Widen the hole in the cortex by driving the 6.2 mm tapered reamer to half the length of the fluted section. Remove the K-wire and reamer. 2 Insert the fracture finger past the fracture if possible. Direct the tip of the finger towards the center of the canal. Insert the spade-tip guidewire on oscillate (gold tip first) through the hole in the finger handle and into the canal. 3 Remove the fracture finger, leaving the guidewire in place, and ream the distal and proximal portion with the 6.2 mm/3.2 mm reamers. Optional Steps I 11 Optional Steps—Nail Insertion With Guide Retain the guidewire. Place the insertion guide over the guidewire and into the distal fragment. Remove the inner cannula (with the round, white handle) and guidewire, retaining the V-channel in the canal. Optional Steps—Compression Technique Compression Driver When compression is desired, it must be performed prior to inserting any distal screws. Move the outrigger slide to the “COMP” position. Insert the drill guide sleeve and 2 mm drill guide into the most distal 2.7 mm hole in the outrigger. Drill, measure, and insert the corresponding 2.7 mm screw. 12 I Optional Steps Thread the compression driver into the back of the outrigger attachment screw and turn clockwise to compress the fracture. Keep the compression driver in place to maintain compression until another distal screw is implanted or it is time to insert the end cap, which must be used while in compression mode. Maximum achievable compression is 2.5 mm. FibuLock ® Fibular Nail Sizes Left 130 mm 180 mm 3.0 mm Right 130 mm 180 mm 130 mm 3.8 mm 180 mm 130 mm 3.0 mm 180 mm 3.8 mm 2.7 mm Screw 12 mm-34 mm 40 mm 30 mm 19 mm 14 mm 10 mm 13 mm 5 mm and 6 mm 6o 130 mm and 180 mm FibuLock Fibular Nail Sizes I 13 14 I Back Table Layout Off se t Gu id e Im pa ct or Ca p Ca Pr nn oxi ul ma at l ed Re , 3 am .2 e m r, m Ca nn D ul ista at l ed Re , 6 am .2 e m r, m KW ire 1.6 G m uide m w × 1 ire 2 , in Back Table Layout Outrigger With Attachment Screw T1 0 m m Fr ac tu re Fi ng er He xa lo an be d Dr Ha iv nd er le Dr ill, 2 m m Sl ee ve Dr ive r Dr ill Gu id e, 2 Dr ill Gu id e Ac tu at io n Back Table Layout Guidewire, Spade Tip, 1.1 mm Back Table Layout I 15 Ordering Information FibuLock® Fibular Nail System (AR-8973S) Product Description Item Number Targeting Guide AR-8973-01 Outrigger Compression Screw Guide AR-8973-02 Hub Attachment Screw AR-8973-03 Impactor Cap AR-8973-04 Compression Driver AR-8973-05 Tissue Protector, double-sided AR-8973-06 Drill Guide Sleeve AR-8973-07 Drill Guide, 2 mm AR-8973-08 Drill, syndesmosis, 2.5 mm AR-8973-25 Drill Guide, syndesmosis, 2.5 mm AR-8973-09 Drill, syndesmosis TightRope® implant, 3.7 mm AR-8973-37 Drill Guide, syndesmosis TightRope Implant, 3.7 mm AR-8973-10 FibuLock Hexalobe Driver, T10 AR-8973-11 FibuLock Hexalobe Driver, T15, cannulated AR-8973-12 Fracture Finger/Guidewire Inserter AR-8973-13 Implant Insertion Guide AR-8973-14 Parallel Drill Guide, 1.6 mm AR-8973-15 FibuLock Nail Tray Insert AR-8943C-FN FibuLock Nail Caddy-Screw Insert AR-8943C-FNS Implants FibuLock Removal Kit, sterile Product Description Item Number Product Description Item Number Fibula Nail, left, 3.0 × 130 mm AR-8973L-30-130 AR-8973RK Fibula Nail, right, 3.0 × 130 mm AR-8973R-30-130 Fibula Nail, left, 3.0 × 180 mm AR-8973L-30-180 Removal Screw Strike Plate Deactivator Fibula Nail, right, 3.0 × 180 mm AR-8973R-30-180 Fibula Nail, left, 3.8 × 130 mm AR-8973L-38-130 FibuLock Implant System, sterile Fibula Nail, right, 3.8 × 130 mm AR-8973R-38-130 Product Description Item Number Fibula Nail, left, 3.8 × 180 mm AR-8973L-38-180 AR-8973DS Fibula Nail, right, 3.8 × 180 mm AR-8973R-38-180 Actuation Driver Proximal Reamer, cannulated, 3.2 mm Distal Reamer, cannulated, 6.2 mm Drill, 2 mm Guidewire, spade tip, 1.1 mm x 22 in Guidewire, coated, 1.6 mm x 12 in, qty. 2 End Cap Low Profile Screws, Stainless Steel Product Description Item Number Nonlocking, cortical, 2.7 mm × 12 mm–24 mm (2 mm increments) AR-8827-12 – 24 Nonlocking, cortical, 3.5 mm × 14 mm–60 mm (2 mm increments), 65 mm, 70 mm, 75 mm, 80 mm AR-8835-14 – 80 Disposables Optional Product Description Item Number Reamer, long, cannulated, sterile, 3.2 mm AR-8973-32LS Reamer, cannulated, sterile, 4.0 mm AR-8973-40S Product Description Item Number Reamer, long, cannulated, sterile, 4.0 mm AR-8973-40LS Washer, 7 mm AR-8870W Syndesmosis TightRope XP Implant System, stainless steel AR-8925SS Products may not be available in all markets because product availability is subject to the regulatory approvals and medical practices in individual markets. Please contact your Arthrex representative if you have questions about the availability of products in your area. 16 I Ordering Information Notes Notes I 17 Notes 18 I Notes Notes Notes I 19 This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience, and should conduct a thorough review of pertinent medical literature and the product’s directions for use. Postoperative management is patient-specific and dependent on the treating professional’s assessment. Individual results will vary and not all patients will experience the same postoperative activity level and/or outcomes. View U.S. patent information at www.arthrex.com/corporate/virtual-patent-marking arthrex.com © 2021 Arthrex, Inc. All rights reserved. LT1-00099-EN_C

FibuLock® Fibular Nail System

FibuLock® Fibular Nail Talon Deployment

Charles J. Jordan, MD, (Miami, FL) describes his experience with the FibuLock® fibular nail and his progression from use in high‐risk patients to younger, high‐demand patients.

FibuLock® Fibular Nail Experience

John T. Riehl, MD, (Pensacola, FL) presents a trimalleolar ankle fracture treated with the FibuLock® nail, a minimally invasive intramedullary nail for the fibula that enables distal and proximal fixation.

Trimalleolar Ankle Fracture Repair Using the FibuLock® Nail

Justin Fleming, DPM, (Somerset, NJ) demonstrates the FibuLock® fibular nail and Knotless TightRope® fixation for fibular fractures. Dr. Fleming reviews tips and pearls including entry point, nail positioning, and syndesmotic TightRope fixation.

3.0 x 130 mm Fibula Nail, Left

FIB30130L

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