BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREW SET 6.5/7.3 5MM DRILL BIT

    MDR report key: 1202046 · Received October 16, 2008

    Report

    Report Number
    MW5008610
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 14, 2007
    Manufacturer
    SYNTHES
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ORTHOPEDIC PROCEDURE USING A 5MM DRILL BIT FROM A ONE TIME USE 6.5/7.3 CANNULATED SCREW SET, THE BIT BROKE OFF IN THE PT'S BONE. PIECES RECOVERED FROM RIGHT FEMUR, SOME PARTICLES REMAINED. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SCREW SET 6.5/7.3 5MM DRILL BIT NONE HTW SYNTHES * 5874846

    Patients

    Seq Age Sex Outcome Treatment
    1