BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLOCENT DRIVE DRILL BIT

    MDR report key: 2194912 · Received July 12, 2011

    Report

    Report Number
    9616696-2011-00107
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 15, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFF
    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 MFR FOR EVAL, IT WAS VISUALLY CONFIRMED THE DRILL BIT WAS BROKEN FROM THE ULTEM SECTION (DRILL BIT GUIDE) OF THE PRODUCT. THE RETURNED DRILL BIT WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECS 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 T2 HUMERUS SURGERY, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE BROKEN DRILL BIT WAS REMOVED FROM THE BONE BY THE SURGEON. IT WAS FURTHER THAT REPORTED THAT THERE WAS NO PT OR USER INJURY AND THERE WAS NO DELAY TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOLOCENT DRIVE DRILL BIT GFF STRYKER IRELAND LTD. 11105017

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR