PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE

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. INVESTIGATION FLOW: VISUAL. VISUAL INSPECTION: THE PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE (P/N: 399.481, LOT NUMBER: T930584) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION IT WAS NOTICED THAT THE BLADE SHAFT IS DISCOLORED AT THE JUNCTION TO THE HANDLE COMPONENT. CONFIRMING THE COMPLAINT CONDITION. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE BLADE IS DISCOLORED. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT PART NUMBER: 399.481, LOT NUMBER: T930584, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: OCT 22, 2008. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 ON AN UNKNOWN DATE, DURING INSPECTION, A BENDING PLIERS WOULD NOT OPEN DUE TO RUST EMBEDDED IN THE GROOVES AND SPRING. THE THREADS OF AN EXTRACTION SCREW WERE STRIPPING, A STARDRIVE SCREWDRIVER SHAFT TIP IS WARPING DUE TO WEAR, 2 PERIOSTEAL ELEVATOR (ROUND AND STRAIGHT) HAVE STAINING BETWEEN THE WOODEN HANDLE AND ELEVATOR, A GRAPHIC CASE TOP COAT OF AUX BIN IS STARTING TO PEEL, AND THE DEPTH GAUGE HANDLE HAS A CRACK THROUGH IT. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR 1 PERIOSTEAL ELEVATOR 3MM CURVED BLADE-ROUND EDGE THIS IS REPORT 3 OF 3 FOR (B)(4).