BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING SCREW INSERTER HANDLE

    MDR report key: 6984672 · Received October 27, 2017

    Report

    Report Number
    3012447612-2017-00596
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    May 1, 2017
    Report Date
    October 27, 2017
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EXAMINED. THE AO ADAPTER COLLAR HAS DISSOCIATED FROM THE REMAINDER OF THE DEVICE AND THE COLLAR WAS NOT RETURNED. THE CAUSE CANNOT BE DETERMINED SINCE NOT ALL OF THE SUBCOMPONENTS WERE RETURNED, PRECLUDING FURTHER EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE RATCHETING MECHANISM WASN'T WORKING ON A HANDLE WHILE INSTALLING A SCREW DURING SURGERY. HOWEVER, DEVICE EVALUATION BY ZIMMER BIOMET PERSONNEL FOUND THE DEVICE TO BE DISASSEMBLED. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764196 RATCHETING SCREW INSERTER HANDLE WRENCH (RATCHETING HANDLES) HXC ZIMMER BIOMET SPINE INC. NA 703089

    Patients

    Seq Age Sex Outcome Treatment
    1