BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE-LIMITING T-HANDLE 7NM

    MDR report key: 12440139 · Received September 8, 2021

    Report

    Report Number
    2939274-2021-05229
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Report Date
    August 10, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10705034769110
    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. THE SUBJECT DEVICE IS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. SERVICE & REPAIR EVALUATION: IT WAS REPORTED THE DEVICE DID NOT MEET CALIBRATION DURING EVALUATION AT SERVICE AND REPAIR. THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED TORQUE TESTING. THE CAUSE OF THE ISSUE IS FAILED HIGH. THE DEVICE WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. 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 # 321.133, SYNTHES LOT # 6025755, SUPPLIER LOT # 596689K08, RELEASE TO WAREHOUSE DATE: 12NOV2008, SUPPLIER: TELEFLEX MEDICAL, INC., NO NCR'S WERE GENERATED DURING PRODUCTION. 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, DURING THE EVALUATION AT SERVICE AND REPAIR, THE TORQUE LIMITING T-HANDLE WAS FOUND TO HAVE FAILED CALIBRATION. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336654 TORQUE-LIMITING T-HANDLE 7NM SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 321.133 596689K08-046 10705034769110

    Patients

    Seq Age Sex Outcome Treatment
    1