DRIVE SHAFT F/RIA 2 L520

Description of Event or Problem

IT WAS REPORTED THE DRIVE SHAFT P/RIA 2 L520 IS BROKEN DURING INTRAMEDULLARY REAMING.

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.INVESTIGATION SUMMARY:THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT DRIVE SHAFT F/RIA 2 L520 HAD BROKEN. THE OBSERVED CONDITION OF THE DEVICE WAS CONSIST WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCE. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE. DRIVE SHAFT F/RIA 2 L520 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE ATTRIBUTED TO COMPONENT FAILURE AND 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 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:PART: 03.404.035.LOT NO: J017965.MANUFACTURING DATE: 16 APRIL, 2025.EXPIRATION DATE: N/A.MANUFACTURING SITE: WERK SELZACH.SUPPLIER: (b)(4).A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED.