ACTIS BROACH SZ 10

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THIS FACILITY HAD MULTIPLE VERSION 1 AND 2 BROACHES BREAK, AND WERE REQUESTING ALL OF THEIR CONSIGNED BROACHES BE SWAPPED OUT FOR VERSION 3 TO AVOID FURTHER BREAKAGES.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY - ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT THIS FACILITY HAD MULTIPLE VERSION 1 AND 2 BROACHES BREAK AND WERE REQUESTING ALL OF THEIR CONSIGNED BROACHES BE SWAPPED OUT FOR VERSION 3 TO AVOID FURTHER BREAKAGES. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE DEVICE DOES NOT FOUND SIGNS OF BREAKAGE AT THE ACTIS BROACH, THE SAMPLE EXHIBITS TRACES OF MULTIPLE USE FOR A LONG PERIOD OF TIME. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE ACTIS BROACH WOULD HAVE NOT CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. ADDED: D4 (LOT), D9, H4 CORRECTED: D4 (PRIMARY UDI NUMBER) H3.