BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 9834974 · Received March 16, 2020

    Report

    Report Number
    2939274-2020-01287
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Report Date
    February 18, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: INITIAL REPORTER IS A SYNTHES EMPLOYEE THE PREVIOUS SERVICE EVENT FOR PART NUMBER 03.641.004 WITH LOT NUMBER(S) H130932-22 HAS BEEN REVIEWED. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(6) 2020 FOR FAILED CALIBRATION. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON (B)(6) 2018 DUE TO FAILED CALIBRATION. THE PREVIOUS SERVICE CONDITION OF FAILED CALIBRATION IS RELEVANT TO THE CURRENT COMPLAINED ISSUE OF FAILED CALIBRATION. THE MANUFACTURE DATE OF THIS ITEM IS OCTOBER 19, 2016. THE SERVICE HISTORY REVIEW IS CONFIRMED. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: 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. A PRODUCT INVESTIGATION WAS COMPLETED: THE SOCKET WRENCH WAS RECEIVED WITH NO VISUAL DEFECTS. 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 IS CONFIRMED. THE RELEVANT DRAWING WAS REVIEWED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2020, DURING TESTING AT SERVICE AND REPAIR, THE TECHNICIAN FOUND OUT THAT THE SOCKET WRENCH HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SOCKET WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300854 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.641.004 H130932-22 10705034720128

    Patients

    Seq Age Sex Outcome Treatment
    1