BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULINK IFS 1.1MM GUIDE WIRE

    MDR report key: 4308450 · Received November 20, 2014

    Report

    Report Number
    3005039508-2014-00014
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    October 17, 2014
    Report Date
    November 3, 2014
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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

    HAMMERTOE PROCEDURE ON (B)(6) 2014 USING THE CANNULINK SYSTEM. IMPLANTED TO MEDIUM, 2.4MM WITH THE 1.1MM GUIDE WIRE WITHOUT INCIDENT. ON (B)(6) 2014 WHEN REMOVING THE 1.1MM GUIDE WIRE, IT BROKE OFF LEAVING PART OF THE GUIDE WIRE STILL EMBEDDED IN THE PT'S FOOT. SHE HAS SCHEDULED SURGERY FOR REMOVAL ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755557 CANNULINK IFS 1.1MM GUIDE WIRE NONE DQX ORTHOHELIX SURGICAL DESIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention