BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISSECTOR, CURVED 4.0 MM X 13 CM

    MDR report key: 1981691 · Received February 8, 2011

    Report

    Report Number
    1220246-2011-00007
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. THE EVALUATION REVEALED BROKEN TEETH ON THE INNER CUTTING WINDOW. FURTHER INVESTIGATION REVEALED THAT THE INNER AND OUTER WINDOW COLLIDED. INNER AND OUTER WINDOW COLLISIONS ARE TYPICALLY CAUSED WHEN THE END USER APPLIES EXCESSIVE BENDING/LEVERAGING FORCE ON THE DEVICE DURING USE. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT NUMBER COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    SHAVINGS IN JOINT. SURGEON WAS PERFORMING A KNEE SCOPE AND NOTICED SHAVINGS IN THE JOINT. HE STOPPED AND TRIED TO REMOVE AS MUCH AS HE COULD BUT THE TINY ONES WERE NOT COMPLETELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISSECTOR, CURVED 4.0 MM X 13 CM BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA ARTHREX, INC. 377420

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other