BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATITUDE 2.5MM SCREW DRIVER

    MDR report key: 4213983 · Received October 24, 2014

    Report

    Report Number
    3004983210-2014-00023
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    TORNIER, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    THIS PART (9030375) THIS WAS BROKEN IN A CASE. THE BROKEN PIECE WAS NOT ABLE TO BE EXTRACTED FROM THE SCREW AND REMAINS IN THE PATIENT. THE TOP WAS BENT OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678592 LATITUDE 2.5MM SCREW DRIVER UNK HXX TORNIER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1