BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT DRIVE DRILL BIT

    MDR report key: 2021343 · Received February 7, 2011

    Report

    Report Number
    9616696-2011-00016
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 11, 2011
    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 TWO DRILL BITS SUBJECT TO THIS MDR WERE RETURNED TO THE MFR FOR EVAL, IT WAS VISUALLY CONFIRMED THE DRILL BITS WERE BROKEN ALONG THE SHAFT. THE RETURNED BITS WERE MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. MFG 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 DURING A HUMERUS SURGERY, TWO RADIOLUCENT DRILL BITS BROKE AT THE SHAFT. IT WAS ALSO REPORTED THAT THE SURGEON REMOVED THE BROKEN PIECES FROM THE SURGICAL SITE AND HAD NO CONCERNS ABOUT PIECES BEING LEFT BEHIND. IT WAS FURTHER REPORTED THAT THERE WAS NO DELAY TO SURGERY 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. 10251017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK