BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR VEPTR NUT

    MDR report key: 11562609 · Received March 24, 2021

    Report

    Report Number
    2939274-2021-01502
    Event Type
    Malfunction
    Date Received
    March 24, 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

    REPORTER IS A J&J EMPLOYEE. INVESTIGATION SUMMARY: SERVICE AND REPAIR HISTORY: THE PREVIOUS SERVICE EVENT FOR PART NUMBER 03.641.004 WITH LOT NUMBER(S) H852117-05 HAS BEEN REVIEWED. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON 24-JUN-2019, FOR HAND PIECE FOR BATTERY POWERED DRIVER DOES NOT WORKED AT ALL. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 28-JUL-2015 DUE TO MOTOR FAILURE. THE PREVIOUS SERVICE CONDITION OF MOTOR FAILURE IS NOT RELEVANT TO THE CURRENT COMPLAINED ISSUE OF HAND PIECE, FOR BATTERY POWERED DRIVER DOES NOT WORK AT ALL. THE MANUFACTURE DATE OF THIS ITEM IS 20-JUN-2017. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. SERVICE AND REPAIR EVALUATION: DURING EVALUATION AT SERVICE AND REPAIR THE SOCKET WRENCH HAS 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 (B)(4). 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 A SHR WAS PERFORMED ON THE SERVICEABLE DEVICE AND IT WAS FOUND THAT THE DEVICE WAS MANUFACTURED ON JUN 20, 2017. A MANUFACTURING RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE NO MANUFACTURING RECORD EVALUATION IS REQUIRED. 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 (B)(6) 2021, DURING EVALUATION AT SERVICE AND REPAIR THE SOCKET WRENCH FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457558 SOCKET WRENCH FOR VEPTR NUT WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.641.004 H852117-05 10705034720128

    Patients

    Seq Age Sex Outcome Treatment
    1