UNK BROACH

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS BROKEN BROACHES/T HANDLE. THE EVENT DID NOT HAPPEN IN SURGERY.

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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE ACTIS BROACH REVEALED THE CONNECTION POST BROKEN FROM THE MAIN DEVICE. ONLY THE CONNECTION POST WAS RETURNED FOR EVALUATION. BASED ON OBSERVATIONS AND LOCATION OF THE BREAKAGE, IT CAN BE DETERMINED THAT IMPACTION FORCES COMBINED WITH HANDLE NOT BEING FULLY SECURED ONTO THE BROACH CAUSED A EXCESSIVE WORKLOAD TO A SPECIFIC PORTION OF THE POST LEADING TO FATIGUE FRACTURE. A DIMENSIONAL INSPECTION AND FUNCTIONAL TESTING WERE NOT PERFORMED DUE TO POST MANUFACTURED DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ACTIS BROACH WOULD HAVE CONTRIBUTED TO THE COMPLAINED 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 A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS RETRIEVED FOR THIS DEVICE.