BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARCO HEADED 2.55 MM K-WIRE

    MDR report key: 4060006 · Received August 12, 2014

    Report

    Report Number
    1043534-2014-00134
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 21, 2014
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT COMPLETE. PRODUCT HAS NOT BEEN RETURNED. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY THE THREADED GUIDE PIN FOR THE HEADED SCREW SNAPPED OFF AT THE THREAD LINE WHEN INSERTED IN TO BONE. THIS SEEMS TO HAVE HAPPENED WITH 2 OF 2 PINS USED. BROKEN PIECE WAS NOT ABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479495 DARCO HEADED 2.55 MM K-WIRE HWC WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1