BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSTITCH SUTURING DEVICE HANDLE

    MDR report key: 2993046 · Received March 1, 2013

    Report

    Report Number
    3006524618-2013-00091
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLANTAR PLATE REATTACHMENT PROCEDURE USING THE SMARTSTITCH SUTURING DEVICE HANDLE, THE SILVER HANDLE WAS STICKING AND THE SUTURES WERE NOT LOADING PROPERLY. THE SURGEON DECIDED TO COMPLETE THE PROCEDURE USING A COMPETITOR'S DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89837 SMARTSTITCH SUTURING DEVICE HANDLE INJECTOR, HAND-HELD KOG ARTHROCARE CORPORATION H865400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other