BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND FLUTED BUR, REGULAR

    MDR report key: 1950118 · Received December 8, 2010

    Report

    Report Number
    9616696-2010-00365
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT AT THE TIME OF MANUFACTURE. THE BUR SUBJECT TO THIS EVENT WAS RETURNED TO THE MFR FOR EVAL. THE PART WAS MEASURED WHERE POSSIBLE, AND THE REPORTED EVENT WAS CONFIRMED THROUGH MEASUREMENT OF THE RETURNED BUR. ADD'L PROCESS CONTROLS HAVE SINCE BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MASTOID SURGICAL PROCEDURE, THE BUR DID NOT CUT. IT WAS ALSO REPORTED THAT THERE WAS NO INJURY TO THE PT. IT WAS FURTHER REPORTED THAT ANOTHER BUR WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND FLUTED BUR, REGULAR DRILLS BURS, TREPHINES & ACCESSORIES HBE STRYKER IRELAND LTD. 09085017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK