BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIOSTEAL ELEVATOR

    MDR report key: 3074356 · Received March 28, 2013

    Report

    Report Number
    3074356
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SYNTHES, INC.
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    AT APPROXIMATELY 0832, WHILE SURGERY WAS BEING PERFORMED, THE INSTRUMENT BROKE INTO MANY PIECES. THE HANDLE OF THE INSTRUMENT BROKE INTO SEVERAL PIECES AND MANY OF THEM FELL INTO THE PATIENT'S WOUND. THE SURGEON IRRIGATED THE WOUND VERY WELL AND MANUALLY REMOVED ALL VISIBLE PIECES. THE SURGEON STATED THAT HE CAN NOT BE SURE THAT ALL OF THE PIECES ARE REMOVED. THE INSTRUMENT WAS REMOVED FROM THE FIELD, INSPECTED BY MYSELF, AND THE SYNTHES REP. A PHOTO WAS TAKEN OF THE INSTRUMENT AND IT WAS TRANSPORTED TO THE STERILE PROCESSING DEPARTMENT (SPD). THE MANAGER OF SPD WAS NOTIFIED. THE NOM OF SURGERY WAS ALSO NOTIFIED. WE ARE UNABLE TO RETURN THIS EQUIPMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127606 PERIOSTEAL ELEVATOR GUIDE, SURGICAL, INSTRUMENT, FZX SYNTHES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR