BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL STOP

    MDR report key: 2841272 · Received November 21, 2012

    Report

    Report Number
    2530088-2012-01010
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 28, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE RETURNED DRILL STOP SHOWS SIGNS OF WEAR OVER THE ENTIRE PART. THE ENTIRE PERIMETER OF THE INNER EDGE OF THE PLUNGER MECHANISM HAS SEVERAL WEAR MARKS, SMALL DINGS AND GOUGES ON IT. A SMALL PIECE OF CLEAR TAPE EXISTS ON THE MAJOR O.D. WHICH IS NOT A RESULT OF THE MANUFACTURING PROCESS.THE RETURNED DRILL STOP WAS MANUFACTURED IN AUGUST 2004 AND IS OVER 8 YEARS OLD. THE DEVICE SHOWS SIGNS OF WEAR OVER THE ENTIRE PART. THE DESIGN WAS REVIEWED, IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DRILL STOP IS MADE FROM 17-4PH MATERIAL WHICH IS A STANDARD MATERIAL USED TO MAKE SYNTHES INSTRUMENTS. THE EXTENSIVE WEAR OF THE PLUNGER MECHANISM ON THE RETURNED DRILL STOP AND THE AGE OF THE DEVICE SUGGEST IT WAS USED BEYOND ITS USEFUL LIFE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DURING A TFN HIP NAILING PROCEDURE, THE SURGEON WAS REAMING WITH THE DRILL BIT WITH APPLIED PRESSURE. THE DRILL BIT ADVANCED FURTHER THAN IT WAS SUPPOSE TO. IT IS UNCERTAIN IF THE DRILL STOPPER WAS IN CORRECTLY BECAUSE THE DRILL STOPPER SLIPPED. THE DRILL BIT PERFORATED THE FEMORAL HEAD, THE SURGEON PULLED THE DRILL BIT BACK TO FINISH THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL STOP DRILL STOP HTW SYNTHES BRANDYWINE 4777896

    Patients

    Seq Age Sex Outcome Treatment
    1