BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 SYNTHES DRILL BIT

    MDR report key: 3807156 · Received May 9, 2014

    Report

    Report Number
    MW5036058
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 21, 2014
    Manufacturer
    SYNTHES, INC.
    Product Code
    HWE
    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-TALAR FUSION WITH SCREWS, AUTOGRAFT AND ALLOGRAFT). A DECISION WAS MADE TO NOT REMOVE THE BIT, THEREFORE, IT IS RETAINED. 00345420-2014-001. REFERENCE MFR REPORT NUMBER: 2520274-2014-00645.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281301 2.0 SYNTHES DRILL BIT DRILL BIT HWE SYNTHES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other