TALON DISTALFIX PROXIMAL FEMORAL NAIL

Description of Event or Problem

A BROKEN NAIL WAS DISCOVERED ON (B)(6) 2015 DURING SURGERY TO REMOVE THE NAIL AND REPLACE IT WITH A HIP IMPLANT DUE TO A NON-UNION. THE NAIL WAS ORIGINALLY IMPLANTED (B)(6) 2014 AND WAS WALKED ON FOR A PERIOD OF NINE MONTHS. THE PT IS A MALE (B)(6) LBS WITH A BMI OF 32.14. HE HAS POOR HEALING QUALITIES AND AS NOTED IN X-RAYS HIS FEMORAL NECK SUBSIDED INTO THE FEMORAL CANAL FULLY LOADED THE NAIL/LAG SCREW JUNCTION. EVEN THOUGH THIS NAIL FAILED AT THE LOCATION, IT DID NOT DISPLACE BECAUSE THE LAG SCREW REMAINED FIXED LATERALLY IN THE CORTICAL BONE.

Additional Manufacturer Narrative

REVIEW OF DEVICE HISTORY RECORDS INDICATE THE PRODUCT MET ALL QUALITY INSPECTIONS AND WAS RELEASED WITHIN SPECIFICATIONS. THE RETURNED DEVICE WAS INSPECTED ON (B)(6) 2015 AND A FATIGUE CRACK PROPAGATION (LATERAL TO MEDIAL) WAS VISUALIZED ACROSS THE LAG SCREW/NAIL JUNCTION. THIS IS CONSISTENT WITH THE EVENT DESCRIPTION OF PATIENT LOAD BEARING OF A NON-UNION FRACTURE OVER 9 MONTHS. THE REVIEW OF THE DEVICE FOUND NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS. POTENTIAL NAIL BREAKAGE HAD BEEN CONSIDERED IN THE CORRESPONDING RISK MANAGEMENT FILE (RMF). THE RMF CONSIDERS NON-UNION A TYPICAL COMPLICATION OF PROXIMAL FEMORAL NAIL PROCEDURES. THE SURGICAL TECHNIQUE GUIDE AND PRODUCT INSERT STATE THAT THIS TYPE OF EVENT CAN OCCUR.