BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2298667 · Received September 30, 2011

    Report

    Report Number
    2298667
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    SYNTHES, INC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, MD NOTICED THAT DRILL BIT WAS BROKEN. MD REMOVED DRILL BIT PIECE. MINI C-ARM IMAGE TAKEN AND REVIEWED BY MD. MD STATES "DRILL BIT PIECE HAS BEEN RETRIEVED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SYNTHES MODULAR HAND SET DRILL BIT HTW SYNTHES, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR