DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON WAS IMPACTING DRIVING CAP IN THE PRESCRIBED FASHION, THE INSTRUMENT BROKE IN HALF IN THE MIDDLE OF THE SPAN OF THREADS WHICH THREAD INTO THE INSERTION HANDLE. BOTH PIECES WERE RETRIEVED AND THE INSTRUMENT WAS IMMEDIATELY DEEMED TO BE NO LONGER FUNCTIONAL. IN ADDITION, DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE CARBON FIBRE UNDERSIDE OF THE ARCH-SHAPE OF INSERT-HANDLE HYBRID HAD BECOME ROUGH AND SHARP AND NO LONGER SMOOTH, AS IT WAS ONCE. IN ADDITION, DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE THIN, DELICATE METAL TIPS OF TWO (2) DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/ HAD BECOME BENT AND DAMAGED. THESE TWO ITEMS WERE ASSESSED AS BEING NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D10 H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY ==> PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.