BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX

    MDR report key: 1222210 · Received November 5, 2008

    Report

    Report Number
    MW5008895
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HXI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WIRE BROKE AS IT WAS BEING PASSED THROUGH PT DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX GRAFT PASSING WIRE HXI ARTHREX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other