BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-COUPLING GAUTHIER 103800

    MDR report key: 2487869 · Received March 6, 2012

    Report

    Report Number
    9615741-2012-00014
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 6, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A SURGICAL PROCEDURE, THE SURGEON WAS USING THE DEVICE TO INSERT A QWIX SCREW WHEN THE DEVICE HANDLE BROKE INTO TWO PIECES. THE SURGERY TIME WAS PROLONGED BY ABOUT THREE MINUTES. THERE WAS NO ADVERSE OUTCOME FOR THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1