BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION KNEE INSTRUMENT

    MDR report key: 2111201 · Received May 26, 2011

    Report

    Report Number
    1644408-2011-00304
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - A 5MM BASEPLATE SCREW BECAME STUCK. THE SURGEON ATTEMPTED TO REMOVE THE STUCK SCREW WITH A 3.5 SCREW DRIVER. THE SCREW HEAD WAS SUBSTANTIALLY STRIPPED, WHILE ATTEMPTING TO REMOVE THE SCREW. THE SURGEON STATED THE SCREW DRIVER HEAD FAILED AND REQUESTED IT TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE INSTRUMENT TIBIAL HEX HEAD SCREW DRIVER HXX ENCORE MEDICAL, L.P. 34209L01

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR