BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TFN REAMER

    MDR report key: 4033891 · Received August 21, 2014

    Report

    Report Number
    4033891
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 21, 2014
    Manufacturer
    SYNTHES INC
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A INTRAMEDULLARY FIXATION OF THE LEFT FEMORAL NECK FRACTURE. WHILE THE DOCTOR WAS USING A TFN (TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM) REAMER, THE TIP OF THE REAMER BROKE. TWO PIECES WERE REMOVED. THE BROKEN REAMER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE CONTINUED WITH NO ADVERSE OUTCOME TO THE PATIENT. THE BROKEN REAMER WAS TERMINALLY CLEANED AND GIVEN TO THE SYNTHES SALES REPRESENTATIVE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505376 TFN REAMER MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR