BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCALIBUR, 5.5MM X 13CM

    MDR report key: 1962005 · Received January 17, 2011

    Report

    Report Number
    1220246-2010-00264
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 27, 2010
    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

    PATIENT DEMOGRAPHICS (DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED, BUT NOT PROVIDED. 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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. THE EVALUATION REVEALED METAL GOUGING FOUND AT THE PROXIMAL END OF THE CUTTING WINDOW ON THE INNER SHAFT. THIS IS TYPICALLY CAUSED WHEN THE USER APPLIES EXCESSIVE BENDING/LEVERAGING FORCE ON THE DEVICE DURING USE OR FROM USER MECHANICAL DAMAGE TO DEVICE SUCH AS HITTING THE DEVICE WITH ANOTHER DEVICE OR GRINDING AGAINST A HARD SURFACE. 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

    IT WAS REPORTED THAT THE SHAVER BLADE WAS SPITTING METAL SHAVINGS INTO THE JOINT. SWITCHED TO ANOTHER BLADE TO COMPLETE THE CASE. METAL SHAVINGS REMAIN UNRETRIEVED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCALIBUR, 5.5MM X 13CM BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA ARTHREX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other