BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQ LIMITING HANDLE - 4.5MM QK COUPLING

    MDR report key: 12705916 · Received October 27, 2021

    Report

    Report Number
    2939274-2021-06333
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    January 1, 2021
    Report Date
    October 1, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034817569
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE TORQUE LIMITING HANDLE HAD FAILED IN CALIBRATION. THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED TORQUE TESTING AND WAS OUT OF CALIBRATION. THE MINIMUM TORQUE PEAK ATTAINED DURING EVALUATION WAS 3.156 NM WHICH IS OUT OF THE SPECIFIED LIMIT 3.2 NM-3.7 NM FOR THE PART. THE DEVICE WILL BE SENT BE SENT FOR SERVICE AND REPAIR. 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 # 03.835.043; SYNTHES LOT # H892214-21; SUPPLIER LOT # H892214-21; RELEASE TO WAREHOUSE DATE: 10 SEP2020; SUPPLIER: AVALIGN TECHNOLOGIES-NEMCOMED. NO NCRS WERE GENERATED DURING PRODUCTION. 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. 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 TORQ LIMITING HANDLE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TORQ LIMITING HANDLE - 4.5MM QK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602804 TORQ LIMITING HANDLE - 4.5MM QK COUPLING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.835.043 H892214-21 10705034817569

    Patients

    Seq Age Sex Outcome Treatment
    1