BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-COUPLING GAUTHIER 103800

    MDR report key: 1942018 · Received November 9, 2010

    Report

    Report Number
    9615741-2010-00057
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    NEWDEAL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    INTEGRA'S DISTRIBUTOR REPORTED THAT TWO T-HANDLE QUICK COUPLING INSTRUMENTS FOR THE QWIX LOWER EXTREMITY FIXATION INSTRUMENT SET WERE RETURNED TO THEM AND WERE FOUND TO HAVE A COMPLETE BREAKAGE IN THE MIDDLE OF THE BLUE 'PLASTIC' HANDLE. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO TO DETERMINE IF THIS OCCURRED DURING A SURGICAL PROCEDURE. NO ADDITIONAL INFO IS AVAILABLE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK-COUPLING GAUTHIER 103800 NA LXH NEWDEAL EAFV

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.