BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING

    MDR report key: 9128940 · Received September 27, 2019

    Report

    Report Number
    2939274-2019-60918
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Report Date
    July 31, 2019
    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

    INITIAL REPORTER IS COMPANY REPRESENTATIVE. INVESTIGATION SUMMARY: PART # 321.133. SYNTHES LOT # 5021918. SUPPLIER LOT # 554839K05. RELEASE TO WAREHOUSE DATE: JUNE 24TH 2005. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS (NCR) 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. 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. THE CUSTOMER REPORTED THE ITEM REQUIRED CALIBRATION TESTING. THE REPAIR TECHNICIAN REPORTED THE ITEM FAILED CALIBRATION TESTING. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WAS SENT TO THE VENDOR FOR RE-CALIBRATION. THE DEVICE WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE DEVICE WAS DEEMED SERVICEABLE AND 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 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) 2019, DURING TESTING AT SERVICE AND REPAIR, A TORQUE LIMITING HANDLE FAILED IN CALIBRATION TESTING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6 MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923688 TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 321.133 5021918 10705034769110

    Patients

    Seq Age Sex Outcome Treatment
    1