BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSTITCH M-CONNECTOR

    MDR report key: 2922103 · Received January 15, 2013

    Report

    Report Number
    3006524618-2013-00038
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ARTHROCARE CORP
    Product Code
    KOG
    PMA / PMN Number
    K022229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR USING THE OPUS SMARTSTITCH M CONNECTOR SUTURING DEVICE, THE NEEDLES WOULD NOT FULLY DEPLOY. THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21535 SMARTSTITCH M-CONNECTOR SUTURE UNITS KOG ARTHROCARE CORP 1025937

    Patients

    Seq Age Sex Outcome Treatment
    1 Other