Ankle Fracture System Surgical Technique STRENGTH FROM WITHIN
Ankle Fracture System The Sonoma FibuLock nail is the first intramedullary device that has the same indications as plates and delivers anatomic reductions with all of the other advantages of intramedullary nailing. TRIANGULATION TALONS Provide proximal fixation Over 4,000 implantations without a known breakage May be easily deactivated for removal SPECIFICATIONS: 3.0mm and 3.8mm diameters 130mm and 180mm lengths 316L stainless steel SYNDESMOSIS FIXATION 3.5mm screws (40-70mm) Applicable for suture button-style fixation Nail geometry ensures screws are parallel to the plafond MULTIPLANAR SCREWS 2.7mm cortical Locking COMPRESSION SLOT AND SCREW Allows 2.5mm of compression END CAP (OPTIONAL) Locks in compression Prevents bone ingrowth
Plate Features In A Nail SYNDESMOSIS FIXATION and COMPRESSION Simple SYNDESMOSIS The anatomic angulation of the FibuLock nail combined with the screw targeting outrigger ensures the syndesmosis screw will be parallel to the plafond. Quick Thread screws bore into bone twice as fast as traditional screws to expedite the procedure. Patented COMPRESSION The FibuLock nail features a patent-pending mechanism that provides 2.5mm of compression.
Table of Contents Instrument Layout 5 Step 1 Marking the Skin 6 Step 2 Reduction 7 Step 3 Entry Point 8-9 Step 3a K-wire Trajectory Technique 10 Step 4 Distal Reaming 11 Step 5 Insert the Guide Wire 12 Step 6 Proximal Reaming 13 Step 7 Position the Insertion Guide 14 Assemble the Outrigger 15 Step 8 Insert the Nail 16 Step 9 Actuate the Nail 17 Step 10a Compression Technique 18 Step 10b 2.7mm Distal Screws 19 Step 11a 3.5mm Syndesmosis Screws 20 Step 11b Suture Buttons 21 Step 12 Insert the End Cap 22 Step 13 Medial Malleolus Technique 23 Specifications BC
3.2mm Proximal Reamer* Drill Guide Sleeve 2mm Drill Guide 2mm Drill* 2.5mm hex Driver and Handle Actuator* Guide Wire* Outrigger with Attachment Screw * Disposable sterile instrument included in ST6100 FibuLock Nail Procedure Pack Back Table Layout Impactor Cap 6.2mm Distal Reamer* 12 1.6mm K-wire* 5
Step 1 Marking the Skin Draw a dotted line on the skin over the axis of the fibula. A semi-circle is drawn around the curvature of the distal fibula tip. A K-wire can be placed on the skin and aligned with the fibula axis using fluoroscopy. The K-wire can then be used as a guide to mark the skin. 6
Step 2 Reduction The fracture can either be reduced percutaneously with reduction forceps or through a small incision. Percutaneous reduction can be achieved by tractioning and internally rotating the distal fragment with forceps; then applying a second forceps to hold the reduction at the fracture. Take multiple anterior and lateral fluoroscopy views to ensure the reduction is aligned. A mini incision over the fracture is helpful to directly reduce older fractures or to ensure an anatomic reduction. Clamping is Critical! To maintain the reduction, ensure it stays clamped throughout the procedure. 7
Step 3 Entry Point Establish the entry point using the 1.6mm K-wire and Tissue Protector. Take multiple anterior and lateral fluoroscopy views to ensure the K-wire is in the center of the canal. Lateral View: Aligned with canal axis A/P or Mortise View: At the lateral edge of the articular facet towards the center of proximal canal Drive the K-wire past the fracture if possible OSCILLATE 8
Important Note: Placing the K-wire too lateral can result in a breached cortex with the 6.2 reamer Use the K-wire Offset Guide to fine-tune placement and direction. Use oscillation to help the K-wire deflect off of canal walls. Fluoroscopy templates are available to help determine the correct entry point. If the K-wire cannot get up the canal go to Step 3a. K-wire Offset Guide 9
Step 3a: K-wire Trajectory Technique This technique should be used if the entry point is right but the trajectory is off. Trajectory is too anterior Retract the K-wire so it is about 15-20mm into the distal fibula. Using the Tissue Protector and 6.2mm Tapered Reamer, widen the hole in the cortex by reaming just to the end of the K-wire. Use the 6.2mm reamer to redirect the K-wire up the canal center. The K-wire can be inserted with the blunt end first to prevent cortex breaching. After the K-wire is up the canal, continue to Step 4 of the technique. 10
Step 4 Distal Reaming Ream the distal fragment with the 6.2mm Tapered Reamer, over the K-wire and through the Tissue Protector, to the end of the Reamer flutes. OSCILLATE Secondary depth indicator when tissue protector is used End of the Reamer flutes Use oscillation to keep rotation from turning the fragment. 11
Step 5 Insert the Guide Wire Retain the 6.2mm Reamer and remove the K-wire. Feed the Guide Wire (gold end first) through the Reamer and up the proximal canal. OSCILLATE Guide Wire Inserter Oscillating power can be used to advance the Guide Wire. The Guide Wire Inserter can be used to help direct the Guide Wire beyond the fracture. 12
Step 6 Proximal Reaming Drive the 3.2mm Reamer over the Guide Wire and through the Tissue Protector, until the depth indicator collar is within the bone. If chatter is not evident, repeat with the 4.0mm Reamer. Use the corresponding long Reamers when indicated. The proper nail diameter is 0.2mm smaller than the final Reamer diameter. OSCILLATE Depth Indicator Collar Secondary depth indicator when tissue protector is used Use oscillation to keep rotation from turning fragment. The reduction is commonly rechecked after this step. 13
Step 7 Position the Insertion Guide Retain the Guide Wire. Place the Insertion Guide over the Guide Wire and into the distal fragment. Remove the Inner Cannula (with the round, white handle) and Guide Wire, retaining the U-Channel in the entry portal. U-Channel Confirm the final reduction prior to insertion of the nail. Place the Insertion Guide beyond fracture when possible to help the nail span the fracture. 14
Assemble the Outrigger with the Nail Nail shaft angles up towards Outrigger 15
Step 8 Insert the Nail Attach the appropriate nail (diameter, length, side) to the Outrigger. Confirm the reduction has been maintained. Insert the nail into the fibula using the Insertion Guide and Impactor Cap. Seat the nail with gentle mallet taps to prevent fracture displacement. 3.2mm Reamer = 3.0mm Nail 4.0mm Reamer = 3.8mm Nail Outrigger should be positioned lateral and parallel with the fibula. Withdraw the Insertion Guide as the nail is inserted to prevent jamming. The end of the nail is determined with fluroscopy using a K-wire through the END hole in the Outrigger. Position of the distal syndesmotic screw can be determined with a K-wire in the adjacent K-wire hole. The nail should be countersunk if fracture compression is planned. Provisional fixation K-wires can be placed through the Outrigger to maintain distal fragment position. Recheck reduction after nail insertion. 16
Step 9 Actuate the Nail Remove the Impact Cap. Turn the Actuation Driver until it clicks to release the talons. Confirm the Outrigger is positioned lateral prior to actuation. Hold the Outrigger while actuating to prevent rotation. Do not rotate the nail after talon actuation. Remove the Actuation Driver prior to screw placement. 17
Step 10a Compression Technique When compression is desired, it must be performed prior to inserting any other distal screws. Move the Outrigger Slide to the COMP position. Insert the Drill Guide Sleeve and 2mm Drill Guide into the most distal 2.7 hole in the Outrigger. Drill, measure, and insert the corresponding 2.7mm screw. Thread the Compression Driver into the back of the Outrigger Attachment Screw and turn it 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. Ensure the Compression Screw Guide stays in the COMP position during drilling and screwing. 18
Step 10b 2.7mm Distal Screws Ensure the Outrigger Slide is in the Static position. Insert the Drill Guide Sleeve and 2mm Drill Guide into a 2.7 hole in the Outrigger. Drill, measure and insert the appropriate 2.7mm screw through the Drill Guide Sleeve. Laser marks on the driver shaft correspond to the different screw positions. The proximal lateral-to-medial screw is the most commonly used. Hold the sleeve in place while drilling and inserting screws. Select the shorter length screw when between sizes. Screws should be unicortical because they are locking. Confirm the screw passes through the nail by re-inserting the Actuation Driver. Laser marks on the driver shaft correspond to the different screw positions. Retract the Drill Guide Sleeve to visualize the screw head during final tightening. The 2.5mm Cannulated Driver may be preferred to maximize hex engagement. 19
Step 11a 3.5mm Syndesmosis Screws Insert the Drill Guide Sleeve and 2.5mm Drill Guide through the desired 3.5 syndesmosis screw hole in the Outrigger. Drill through the Nail and bones with the 2.5mm Drill. Read the length indicated by the laser mark and Drill Guide. Insert the corresponding 3.5mm screw through the Drill Guide Sleeve using the 2.5mm Hex Driver. Hold the guides in place while drilling and inserting screws. Use light pressure on the drill to minimize deflection. Retract the Drill Guide Sleeve to visualize the screw head during final tightening. 20
Step 11b Suture Button Syndesmosis Fixation Insert the Drill Guide Sleeve and 3.5mm (black) Drill Guide through the desired 3.5 syndesmosis hole in the Outrigger. Drill through the Nail and bones with the noncannulated 3.5mm Drill. Insert the chosen suture button through the 3.5 hole in the Outrigger and then tighten the suture button device. Sterile mineral oil can be placed on the button of the syndesmosis device to ease passage through the FibuLock syndesmosis hole The hole in the Nail is 3.6mm 21
Step 12 Insert the End Cap Remove the Outrigger by loosening the Hub Attachment Screw. Insert a 1.25mm K-wire into the nail end. Insert the End Cap over the K-wire into the nail using the Cannulated 2.5mm Hex Driver. Fully seated End Cap The End Cap must be inserted if the most distal (compression) screw is utilized. If cross-threading is a concern, turn the End Cap counterclockwise until it is seated and then reattempt insertion. Confirm End Cap seating fluoroscopically. 22
Step 13 Medial Malleolus Technique The fracture is generally first reduced with forceps. Insert a 1.25mm K-wire with the 2.7mm/1.25mm medial malleolar drill guide. Determine screw length by placing the screw depth gauge over a K-wire. (A) Drive the 2.7mm cannulated reamer down the length of the K-wire. Drive the appropriate cannulated screw over the K-wire with the cannulated 2.5mm hex driver. A Secondary screw measurement gauge The K-wire should be placed perpendicular to the fracture line and be driven to the desired depth of the cannulated screws. When determining screw length and deciding between sizes, choose the smaller screw length to ensure the screw will not penetrate into the joint. 23
SPECIFICATIONS 5mm & 6mm 13mm Catalog # Label Description FIB30130L 3.0x130mm Sonoma FibuLock Nail, Standard Left FIB30130R 3.0x130mm Sonoma FibuLock Nail, Standard Right FIB30180L 3.0x180mm Sonoma FibuLock Nail, Long Left FIB30180R 3.0x180mm Sonoma FibuLock Nail, Long Right FIB38130L 3.8x130mm Sonoma FibuLock Nail, Standard Left FIB38130R 3.8x130mm Sonoma FibuLock Nail, Standard Right * FIB38180L 3.8x180mm Sonoma FibuLock Nail, Long Left * FIB38180R 3.8x180mm Sonoma FibuLock Nail, Long Right *Available upon request 25 o L/M screws 3mm & 3.8mm 30 o Single A/P screw 3.5mm 2.5 mm Syndesmosis screws 130mm & 180mm 40mm 30mm 40, 45, 50, 55, 60, 65, 70mm 19mm 14mm 10mm 6mm Syndesmosis Screws Catalog # Label Description CO3540-D 3.5mm x 40mm Quick Thread Cortical Screw CO3545-D 3.5mm x 45mm Quick Thread Cortical Screw CO3550-D 3.5mm x 50mm Quick Thread Cortical Screw CO3555-D 3.5mm x 55mm Quick Thread Cortical Screw CO3560-D 3.5mm x 60mm Quick Thread Cortical Screw CO3565-D 3.5mm x 65mm Quick Thread Cortical Screw CO3570-D 3.5mm x 70mm Quick Thread Cortical Screw 6 o 6mm 2.7mm 2.0mm 5mm End Cap Catalog # Label Description FIB6000 Sonoma FibuLock Nail End Cap 0.8mm 7mm 4mm Medial Malleolus Screw Washer Catalog # Label Description WA4000 4.0mm Medial Malleolus Bone Screw Washer 4.0mm 2.7mm Distal Screws Catalog # Label Description SC2712 2.7mm x 12mm Self Tapping Cortical Screw SC2714 2.7mm x 14mm Self Tapping Cortical Screw SC2716 2.7mm x 16mm Self Tapping Cortical Screw SC2718 2.7mm x 18mm Self Tapping Cortical Screw SC2720 2.7mm x 20mm Self Tapping Cortical Screw 40, 45, 50, 55, 60mm Medial Malleolar Screws (cannulated) Catalog # Label Description CA4040-C 4.0mm x 40mm Cancellous Screw, Cannulated CA4045-C 4.0mm x 45mm Cancellous Screw, Cannulated CA4050-C 4.0mm x 50mm Cancellous Screw, Cannulated CA4055-C 4.0mm x 55mm Cancellous Screw, Cannulated CA4060-C 4.0mm x 60mm Cancellous Screw, Cannulated 6mm Sonoma Orthopedic Products, Inc. 1388 Busch Parkway Buffalo Grove, IL 60089 847-807-4378 Phone 847-947-8082 Fax www.sonomaorthopedics.com TM Trademarks and Registered Marks of Sonoma Orthopedic Products, Inc. 2015 Sonoma Orthopedic Products, Inc. All Rights Reserved USA Patents 7,846,162; 7,909,825; 7,914,533 and 7,942,875 USA and International Patents Pending MediTech Strategic Consultants B.V. Maastrichterlaan 127-129 6291 EN Vaals LB-1352 Rev C