BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 11571235 · Received March 25, 2021

    Report

    Report Number
    2939274-2021-01524
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Report Date
    February 24, 2021
    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

    PRODUCT COMPLAINT # (B)(4). REPORTER IS JNJ EMPLOYEE. INVESTIGATION SUMMARY: SERVICE AND REPAIR EVALUATION: DURING TESTING AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE SOCKET WRENCH HAD FAILED IN CALIBRATION. THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED TORQUE TESTING. THE CAUSE OF THE ISSUE IS FAILED HIGH. THE ITEM WILL BE REPAIRED AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 20. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN TUNGSTEN DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND WILL BE RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: PART NUMBER:03.641.004. SYNTHES LOT NUMBER: H852117-01. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: JAN 23, 2020. EXPIRATION DATE: N/A. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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) 2021, DURING EVALUATION AT SERVICE AND REPAIR, THE SOCKET WRENCH FOR VEPTR NUT WAS FOUND TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) IMPLANT INSERTER SH CONNECTION THIS REPORT IS 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469212 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.641.004 H852117-01 10705034720128

    Patients

    Seq Age Sex Outcome Treatment
    1