BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING

    MDR report key: 9153250 · Received October 3, 2019

    Report

    Report Number
    2939274-2019-61173
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Report Date
    September 11, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. DEVICE HISTORY LOT PART # 321.133, SYNTHES LOT # 5110426, SUPPLIER LOT # 558524J05, RELEASE TO WAREHOUSE DATE: 09 NOV 2005, SUPPLIER: BEERE PRECISION MEDICAL INSTRUMENTS, NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW: THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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, THE TORQUE LIMITING T- HANDLE WAS FOUND TO BE FAILING DURING THE AUDIT OF RETURNED DEVICES AT MILLSTONE FACILITY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING THIS IS REPORT IS 5 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947270 TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 321.133 5110426 10705034769110

    Patients

    Seq Age Sex Outcome Treatment
    1