BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROTEK

    MDR report key: 507295 · Received January 12, 2004

    Report

    Report Number
    MW1030824
    Event Type
    Malfunction
    Date Received
    January 12, 2004
    Date of Event
    January 5, 2004
    Report Date
    January 12, 2004
    Manufacturer
    ARTHROTEK
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ACL RECONSTRUCTION, TIP OF ARTHROTEK BONE MULCH SCREW, 10.5 MM X 20 MM BROKE OFF. THE BULK OF THE SCREW WAS REMOVED AND DISCARDED, ALTHOUGH THE VERY TIP OF THE SCREW WAS UNABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROTEK BONE MULCH SCREW HWC ARTHROTEK * 910860

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other