BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR K-WIRES FOR TRS

    MDR report key: 2993291 · Received March 7, 2013

    Report

    Report Number
    8030965-2013-00773
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUE WAS FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING THE QUICK COUPLING FOR A TRAUMA RECON SYSTEM (TRS). IT WAS REPORTED THAT PRIOR TO A PROCEDURE TO TREAT A PATIENT WITH TIBIAL SHAFT FRACTURES, A GREY LIQUID THAT WAS LEAKING FROM THE TRS WAS DISCOVERED. AS THE DOCTOR WAS PREPARING THE QUICK COUPLING IN QUESTION IN A CLEAN AREA, A NURSE FOUND THAT GRAY-COLOURED LIQUID WAS LEAKING OUT FROM THE HOLLOW AND MOVABLE PORTION. THE QUICK COUPLING IN QUESTION WAS CLEANED AND STERILIZED AGAIN, AND THE SAME COLOURED LIQUID WAS REPORTED TO BE LEAKING AGAIN. THE DOCTOR PERFORMED THE OPERATION WITHOUT USING THE QUICK COUPLING. THIS IS REPORT NUMBER 3 OF 4 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97116 QUICK COUPLING FOR K-WIRES FOR TRS HWE SYNTHES GMBH 3543

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR