BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVAL BURR, 12 FLUTE, 5.5MM X 13CM

    MDR report key: 1936117 · Received December 13, 2010

    Report

    Report Number
    1220246-2010-00230
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REC'D AND AN EVAL WAS CONDUCTED. COMPLAINT NOT CONFIRMED. NO PROBLEMS FOUND. RETURNED BURR REVEALED NO BURNT MARKS ON THE SHAFTS, SHRINK TUBING OR THE HUBS. ALSO NO METAL GOUGING FOUND ANYWHERE ALONG INNER AND OUTER SHAFTS. COMPLAINANT STATES THAT THE BURR TORQUED AGAINST THE SKIN AND MADE A BLISTER BUT THIS IS NOT LIKELY AS THE OUTER SHAFT DOES NOT SPIN, THE ONLY PART OF THE BURR WHICH SPINS IS THE INNER SHAFT WHICH IS WELL CONCEALED WITHIN OUTER SHAFT LESS THE BURR TIP (WORKING AREA). DHR NOT REVIEWED AS THE INCORRECT LOT NUMBER WAS GIVEN BY THE CUSTOMER. THE MOST LIKELY CAUSE OF THE EVENT HAS NOT BEEN DETERMINED AND IS STILL UNDERGOING FURTHER INVESTIGATION. IF ADD'L RELEVANT INFO IS REC'D, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SURGEON NOTICED A 2CM SUPERFICIAL BURN OVER LATERAL PORTAL SITE AT COMPLETION OF PROCEDURE. IT WAS REPORTED THAT THE SHAVER WAS TORQUED AGAINST THE SKIN AND A BLISTER MARKER APPEARED AT POINT OF CONTACT WITH BUR. WOUND WAS CLOSED AND PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVAL BURR, 12 FLUTE, 5.5MM X 13CM GFF ( BUR, SURGICAL) GFF ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other