BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SLIDE HAMMER 400 GRAMS

    MDR report key: 10621164 · Received October 2, 2020

    Report

    Report Number
    2939274-2020-04460
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Report Date
    September 10, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZY
    UDI-DI
    10886982197269
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE LOCKING SLIDE HAMMER 400 GRAMS (P/N: 359.225, LOT NUMBER: 3140774) WAS RECEIVED AT US CQ DISASSEMBLED. THE HAMMER HEAD WAS NOT RETURNED AND THE CAPTIVATION NUT WAS RETURNED DISASSEMBLED FROM HAMMER SHAFT BUT IT DOES NOT EFFECT THE FUNCTIONALITY OF THE DEVICE. NO OTHER DEFECTS WERE IDENTIFIED ON THE DEVICE. FUNCTIONAL TEST: FUNCTIONAL TEST WAS NOT PERFORMED AS THE HAMMER HEAD WAS NOT RETURNED WITH THE RETURNED DEVICES. COMPLAINT REPLICATION WAS UNABLE TO BE PERFORMED. DIMENSIONAL INSPECTION: THE INTERNAL DIAMETER OF THE DISTAL END HOLE(MATING FEATURE) ON THE HAMMER SHAFT WAS MEASURED FOR DIMENSIONAL ACCURACY PER RELEVANT DRAWING AND FOUND TO BE CONFIRMING. DOCUMENT SPECIFICATION REVIEW: RELEVANT DRAWINGS WERE REVIEWED. CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED AS THE HAMMER HEAD WAS NOT RETURNED, IT WAS DISCARDED PRIOR TO SALES CONSULTANT INVOLVEMENT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 359.225, SYNTHES LOT NUMBER: 3140774, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 15. MAY 2009. A MANUFACTURING RECORD EVALUATION 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 · 1

    REPORTER IS A J&J SALES CONSULTANT. THE DEVICE HAS BEEN 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 · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE AT THE STERILE PROCESSING DEPARTMENT THE SALES CONSULTANT WAS MADE AWARE OF A HANDLE WITH MINI QUICK COUPLING, WHICH DOES NOT RETAIN SCREWDRIVER BLADE. THE HAMMER HEAD OF THE LOCKING SLIDE HAMMER 400 GRAMS WOULD NOT ATTACH TO THE SHAFT. THE HEAD WAS DISCARDED AND THE OTHER PIECES OF INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM WOULD NOT PROPERLY ASSEMBLE. OTHER PIECES WERE DISCARDED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCKING SLIDE HAMMER 400 GRAMS. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087236 LOCKING SLIDE HAMMER 400 GRAMS HAMMER,SURGICAL FZY WRIGHTS LANE SYNTHES USA PRODUCTS LLC 359.225 3140774 10886982197269

    Patients

    Seq Age Sex Outcome Treatment
    1