BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTHREX

    MDR report key: 1040347 · Received May 7, 2008

    Report

    Report Number
    MW5006789
    Event Type
    Other
    Date Received
    May 7, 2008
    Date of Event
    February 25, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ARTHREX INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2007, PT HAD ALL REPAIR WITH ARTHREX BIO-TRANSFIX SCREW. IN 2008, PT RETURNED FOR LEFT KNEE ARTHROSCOPY WITH DEBRIDEMENT AND REMOVAL OF FOREIGN BODY. FRACTURED PIN DISCOVERED DURING THIS PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX TRANSFIX PIN 5MM X 40 MAI ARTHREX INC. * 79938

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other