BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA BARREL BUR

    MDR report key: 2183484 · Received July 14, 2011

    Report

    Report Number
    2183484
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    METAL FLAKES WERE NOTED COMING FROM 4.0MM BUR BY SURGEON WHILE PERFORMING SHOULDER ARTHROSCOPY. BUR REMOVED FROM FIELD, JOINT PHOTOGRAPHED AND IRRIGATED. THE BUR WAS REPLACED AND JOINT RINSED WITHOUT ANY OBVIOUS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMULA BARREL BUR BUR, SURGICAL GFF ASCENT HEALTHCARE SOLUTIONS 375-941-012 1196466

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR