TALON DISTALFIX PROXIMAL FEMORAL NAIL

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF DEVICE HISTORY RECORDS INDICATE THE PRODUCT MET ALL QUALITY INSPECTIONS AND WAS RELEASED WITHIN SPECIFICATIONS. THE MANUFACTURER'S CLINICAL DIRECTOR WAS PRESENT FOR THE NAIL IMPLANTATION. FURTHER REVIEW AND DISCUSSION WITH PERSONNEL INVOLVED DURING THE CASE INDICATED AN INITIAL MEASUREMENT FOR A 360 MM NAIL TO BE USED, HOWEVER, THE MEASUREMENT INSTRUMENT MAY HAVE BEEN SHIFTED, LEADING TO THE LONGER NAIL SELECTION. THE SURGICAL TECHNIQUE GUIDE CALLS FOR A LATERAL VIEW OF DISTAL FIXATION, WHICH MAY HAVE SHOWN THE FRACTURE DURING THE INITIAL PROCEDURE.

Description of Event or Problem

ON (B)(6) 2014 PT RECEIVED A PROXIMAL FEMORAL NAIL TO TREAT A SUBTROCHANTERIC FRACTURE. MEASURING HAD SUGGESTED A SIZE 380 MM NAIL BE USED, HOWEVER, WHEN THE NAIL WAS FULLY SEATED, IT SEEMED SIGNIFICANTLY MORE DISTAL THAN WHAT THE TEMPLATE INDICATED. DURING THIS PROCEDURE, THE SURGEON DECIDED NOT TO REMOVE THE NAIL AND REPLACE WITH A SHORTER ONE. THE CASE CONTINUED WITHOUT INCIDENT. THE DISTAL TALONS OF THE NAIL WERE DEPLOYED TO ACHIEVE DISTAL FIXATION. A LATERAL VIEW OF THE DISTAL FEMUR AFTER FIXATION DISTALLY WAS NOT OBTAINED. A LAG SCREW WAS PLACED AND LAG SCREW TALONS WERE DEPLOYED. NO COMPRESSION WAS NEEDED AND THE SET SCREW WAS FULLY TIGHTENED. ON (B)(6) 2014 A PT FOLLOW-UP X-RAY IMAGE WAS PROVIDED SHOWING INCORRECT TALON POSITION. FURTHER REVIEW OF THE PT AND A CT SCAN OF THE PT'S DISTAL FEMUR INDICATED THE DISTAL TIP OF THE NAIL HAD BROKEN THROUGH THE ANTERIOR CORTEX OF THE DISTAL FEMUR. ON (B)(6) 2014 THE PROXIMAL FEMORAL NAIL WAS REMOVED WITHOUT INCIDENT, AND THE ORIGINAL FRACTURE WAS PLATED.