BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES

    MDR report key: 2547802 · Received April 20, 2012

    Report

    Report Number
    MW5025144
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 11, 2012
    Manufacturer
    SYNTHES, INC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 4.0 MM DRILL BIT WAS BEING USED TO DRILL A HOLE THROUGH THE PT'S LEFT DISTAL FEMUR. DURING DRILLING, THE DISTAL 1/8 INCH OF DRILL BIT BROKE OFF IN THE MEDIAL FEMUR. THE SURGEON WAS USING FLUOROSCOPY AT THE TIME AND SAW THE EVENT OCCUR. HE ATTEMPTED TO REMOVE THE FRACTURED PIECE OF DRILL WITHOUT SUCCESS. THE SURGEON DETERMINED THAT THE ONLY WAY TO REMOVE THE FRAGMENT WAS TO MAKE A MEDIAL INCISION ON THE PT'S LEG, AND GIVEN THE SIZE AND LOCATION OF THE DRILL TIP, THE HARM CAUSED WITH THE INCISION COULD NOT BE JUSTIFIED. THE PT WAS TOLD OF THE EVENT AND IT WAS REPORTED TO THE MFR'S REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES DRILL BIT HTW SYNTHES, INC 4.0 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other