BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROTEK

    MDR report key: 558943 · Received November 1, 2004

    Report

    Report Number
    MW1033691
    Event Type
    Malfunction
    Date Received
    November 1, 2004
    Date of Event
    October 5, 2004
    Report Date
    October 20, 2004
    Manufacturer
    ARTHROTEK
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING REPAIR OF LEFT QUADRICEPS TENDON, WHILE USING ARTHROTEK CURETEK CARTRIDGE, A PIECE OF THE DRILL BIT BROKE AND 2 MM WAS EMBEDDED IN THE PATELLA AND LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROTEK CUROTEK CARTRIDGE HRX ARTHROTEK 906754 098720

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other