BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND DIAMOND BUR, ELITE

    MDR report key: 1575430 · Received December 22, 2009

    Report

    Report Number
    9616696-2009-00295
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    November 24, 2009
    Report Date
    November 25, 2009
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BURS SUBJECT TO THIS MDR WERE RETURNED FOR EVALUATION. UPON VISUAL EXAMINATION UNDER MICROSCOPE, IT WAS OBSERVED THAT THERE WAS NO DIFFERENCE IN THE DIAMOND COATING BETWEEN RETURNED PARTS AND NEW PRODUCTS TAKEN FROM STOCK. TESTING WAS PERFORMED ON THE RETURNED PARTS AND IT WAS OBSERVED THAT THERE WERE NO ISSUES WITH CUTTING PERFORMANCE AND THE REPORTED EVENT COULD NOT BE REPLICATED. A FULL DOCUMENTATION REVIEW WAS CARRIED OUT, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS ALLEGED EVENT. THE ROOT CAUSE IS UNDETERMINED. ANOTHER PART NUMBER IS ASSOCIATED WITH THIS MDR AS FOLLOWS; 5820-012-040; LOT NO. 09286017; EXPIRY OCT 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A MASTOIDECTOMY SURGICAL PROCEDURE THAT THE BURS WERE DULL. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT IMPACT THE PT'S OUTCOME. IT WAS FURTHER REPORTED THAT OTHER BURS WERE READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND DIAMOND BUR, ELITE DRILLS, BURS, TREPHINES & ACCESSORIES HBE STRYKER IRELAND LTD. 09282017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK