ZIMMER

Description of Event or Problem

WHILE REMOVING MAGNA-FX SCREWS FROM PATIENT'S LEFT HIP, THE CANNULATED SCREWDRIVER BROKE OFF AT THE END. SURGEON SUBSTITUTED THE CANNULATED SCREWDRIVER (JACOBS CHUCK) WAND THE SHANK BROKE OFF. ASSOCIATE THEN DELIVERED SCREWDRIVER, WHICH ROUNDED OFF AT THE END. SZCREWS REMOVED WITH VICE GRIPS AFTER EXTENDED OPERATIVE TIMEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.