BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2875179 · Received October 9, 2012

    Report

    Report Number
    2875179
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    JDR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS SUTURE PASSING WIRE WAS IN USE, IT WAS BENT AND THEN BROKE INTO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * WIRE, GUIDE, CATHETER JDR ARTHREX, INC. NITINOL 1.1MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR