BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT DRIVE DRILL BIT

    MDR report key: 2260301 · Received September 1, 2011

    Report

    Report Number
    9616696-2011-00143
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 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 NOT RETURNED TO THE MANUFACTURER FOR EVAL. THE RRAD (RADIOLUCENT RIGHT ANGLE DRIVE) ATTACHMENT USED WITH THE DRILL BIT WAS RETURNED AND EVALUATED. ON INSPECTION OF THE ATTACHMENT IT WAS CONFIRMED THAT PART OF THE DRILL BIT WAS STILL STUCK IN THE ATTACHMENT. IT WAS VISUALLY CONFIRMED THAT THE DRILL BIT HAD BROKEN FROM THE ULTEM SECTION (DRILL BIT GUIDE) OF THE PRODUCT. LOT NUMBER INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED. THE ATTACHMENT ASSOCIATED WITH THIS MDR IS AS FOLLOWS: PART NUMBER: 4100355000, SERIAL NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T2 HUMERUS SURGERY, THE DRILL BIT BROKE AT THE BASE, WHERE THE BIT IS ATTACHED TO THE RRAD ATTACHMENT. 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 GFF STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR