BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-COUPLING GAUTHIER 103800

    MDR report key: 1480493 · Received July 15, 2009

    Report

    Report Number
    9615741-2009-00019
    Event Type
    Malfunction
    Date Received
    July 15, 2009
    Date of Event
    March 26, 2009
    Report Date
    July 15, 2009
    Manufacturer
    NEWDEAL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SPRING INSIDE THE WHITE PLASTIC RING ON THE PROXIMAL END OF THE DEVICE "T" HANDLE BROKE DURING INSERTION OF A SCREW. THERE WAS NO HARM TO THE PT. THE METAL SPRING WAS REMOVED FROM THE DRIVER DURING THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1