BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT DRIVE DRILL BIT

    MDR report key: 1934580 · Received November 23, 2010

    Report

    Report Number
    9616696-2010-00341
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL BIT SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, IT WAS VISUALLY CONFIRMED THE DRILL BIT WAS BROKEN FROM THE RADIOLUCENT HUB OF THE PRODUCT. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SETTING UP FOR SURGERY, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THERE WAS NO PT OR USER INJURY AND THERE WAS NO DELAY TO SURGERY. IT WAS FURTHER REPORTED THAT ANOTHER DRILL BIT WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOLUCENT DRIVE DRILL BIT DRILLS, BURS, TREPHINES & ACCESSORIES HBE STRYKER IRELAND LTD. 10205017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK