BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN ROTATING HINGLE KNEE SCREW DRIVER

    MDR report key: 1950102 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01268
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIP OF THE SCREWDRIVER IS BROKEN. THE BREAKAGE WAS DISCOVERED UPON THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN ROTATING HINGLE KNEE SCREW DRIVER KNEE INSTRUMENT HXX ZIMMER, INC. 60005412

    Patients

    Seq Age Sex Outcome Treatment
    1