S-ROM*PIN PUNCH

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO DEPUY SYNTHES FOR EVALUATION. REVIEW OF THE PHOTOGRAPHIC EVIDENCE CONFIRMED THE REPORTED ALLEGATION. THE INSTRUMENT WAS BENT AT THE TIP. ADDITIONALLY, THE DEVICE SHOWS AN OVERALL WORN APPEARANCE CONSISTENT WITH NORMAL AND REPETITIVE USE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

Description of Event or Problem

UPON INSPECTION IN MDR AFTER REPROCESSING DEVICE #: 531500 AND DEVICE #: 540030 WERE DISCOVERED DAMAGED/BROKEN. PART #: 531500 IS BENT AND DAMAGED. PART #: 540030 IS BROKEN - T-HANDLE PORTION HAS SEPARATED FROM THE SHAFT OF THE DEVICE. THESE ITEMS ARE FROM LOANER SETS FROM DEPUY SYNTHES CANADA.

Additional Manufacturer Narrative

PRODUCT COMPLAINT #: (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.