BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM HEX DRIVER FOR 5.5MM SCREWS

    MDR report key: 1930132 · Received November 18, 2010

    Report

    Report Number
    9615741-2010-00060
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 18, 2010
    Manufacturer
    NEWDEAL
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    THE REPORTER STATED THAT TWO SCREWDRIVERS BROKE DURING A SURGICAL PROCEDURE USING THE QWIX FIXATION AND POSITIONING SCREWS FOR EXTREMITY RECONSTRUCTION. THE SURGERY WAS COMPLETED USING ANOTHER MANUFACTURER'S SCREWDRIVER. THE PROCEDURE WAS PROLONGED BY ABOUT TWENTY MINUTES. NO ADDITIONAL INFO WAS PROVIDED. INTEGRA HAS REQUESTED ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3MM HEX DRIVER FOR 5.5MM SCREWS NA HXX NEWDEAL

    Patients

    Seq Age Sex Outcome Treatment
    1