BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1972363 · Received January 18, 2011

    Report

    Report Number
    1972363
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 13, 2011
    Manufacturer
    SYNTHES
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    TIP OF THE DRILL BIT BROKE OFF IN THE PATIENT'S ANKLE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SYNTHES DRILL BIT HTW SYNTHES 310.21 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR