BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 SYNTHES DRILL BIT

    MDR report key: 3603236 · Received January 29, 2014

    Report

    Report Number
    MW5034115
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 21, 2014
    Manufacturer
    SYNTHES, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRILL BIT BROKE AND LODGED DEEP WITHIN FUSION MASS DURING SURGICAL REPAIR OF RIGHT ANKLE FRACTURE (RIGHT TIBIA-TALER FUSION WITH SCREWS, AUTOGRAFT AND ALLOGRAFT). A DECISION WAS MADE TO NOT REMOVE THE BIT, THEREFORE, IT IS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62477 2.0 SYNTHES DRILL BIT DRILL BIT HTW SYNTHES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other