BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10NM TORQUE WRENCH 11MM ACROSS THE FLATS

    MDR report key: 14279545 · Received May 4, 2022

    Report

    Report Number
    2939274-2022-01603
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Report Date
    May 3, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXC
    UDI-DI
    10705034772233
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # PC-(B)(4). REPORTER IS A J&J SALES REPRESENTATIVE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10: ADDITIONAL NARRATIVE: D4 H3, H4, H6: PART 388.261, LOT H812484-12: RELEASE TO WAREHOUSE DATE: DECEMBER 03, 2019. SUPPLIER: S.S. WHITE MEDICAL PRODUCTS. NO NON-CONFORMANCE REPORTS (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. H3, H6: A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER RETURNED THE TORQUE WRENCH FOR ROUTINE MAINTENANCE. THE REPAIR TECHNICIAN REPORTED THAT THE DEVICE HAD FAILED CALIBRATION AND FAILED TORQUE TEST IN CLOCKWISE DIRECTION. TORQUE TEST HIGH IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS TORQUE TEST FAILED HIGH. THE EVALUATION WAS CONFIRMED. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING DURING EVALUATION, 10NM TORQUE WRENCH 11MM ACROSS THE FLATS HAS FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244039 10NM TORQUE WRENCH 11MM ACROSS THE FLATS WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 388.261 H812484-12 10705034772233

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown