BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4377323 · Received December 3, 2014

    Report

    Report Number
    4377323
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    November 21, 2014
    Report Date
    December 3, 2014
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRILL BIT 310.63 BROKE INSIDE FEMORAL HEAD. THE PHYSICIAN WAS ABLE TO RETRIEVE THE PIECES USING A C-ARM GUIDANCE AND REMOVE ALL FRAGMENTS AFTER APPROXIMATELY TWENTY MINUTES. PATIENT RECEIVED PROLONGED EXPOSURE OF GENERAL ANESTHESIA. NO OTHER HARM CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782488 * BIT, DRILL HTW SYNTHES (USA) PRODUCTS LLC 310.63 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR