GLENOSPHERE FORCEPS

Additional Manufacturer Narrative

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. UNDER CARE AND HANDLING INSTRUMENTS, IT STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR EXACTING PERFORMANCE." DEVICE REQUESTED, NOT YET RECEIVED.

Description of Event or Problem

THE FOLDED TIP OF THE FORCEPS WAS FRACTURED UPON RETURN FROM THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT OR DELAY IN A PROCEDURE REPORTED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. REVIEW OF THE DEVICE CONFIRMED THE REPORTED CONDITION AS THE TIP OF ONE OF THE FORCEPS ARMS WAS CHIPPED. PRODUCT MOST LIKELY FAILED DUE TO BENDING OVERLOAD WHILE IMPLANTING THE GLENOSPHERE; HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.