BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 9861150 · Received March 20, 2020

    Report

    Report Number
    2939274-2020-01416
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Report Date
    February 24, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXC
    UDI-DI
    10705034720128
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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, H4, H6: PART: 03.641.004, SYNTHES LOT: H130932-20, SUPPLIER LOT: H130932-20, MANUFACTURING SITE: SYNTHES MONUMENT, RELEASE TO WAREHOUSE DATE: OCTOBER 19, 2016, SUPPLIER: (B)(4). REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SERVICE AND REPAIR EVALUATION: DURING EVALUATION AT SERVICE AND REPAIR, THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED HIGH IN CALIBRATION. TORQUE TEST HIGH IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. VISUAL INSPECTION: THE SOCKET WRENCH FOR VEPTR NUT WAS RECEIVED AT US CUSTOMER QUALITY (CQ) WITH NO VISUAL DEFECTS. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS PERFORMED BY SERVICE AND REPAIR AND THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED HIGH IN CALIBRATION. THE COMPLAINT WAS ABLE TO BE REPLICATED THEREFORE, THE COMPLAINT WAS CONFIRMED. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED; SOCKET WRENCH VEPTR II. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED. NO MANUFACTURING ISSUES WERE IDENTIFIED DURING INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A ROOT CAUSE COULD NOT BE DETERMINED, BUT IT IS LIKELY THE DEVICE WAS NOT PROPERLY MAINTAINED AND HAS AN INTERNAL MECHANICAL FAILURE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. 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 J&J EMPLOYEE. 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 ON FEBRUARY 13, 2020, DURING TESTING AT SERVICE AND REPAIR, THE TECHNICIAN FOUND OUT THAT THE SOCKET WRENCH HAS FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324509 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.641.004 H130932-20 10705034720128

    Patients

    Seq Age Sex Outcome Treatment
    1