BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTSTITCH WITH MAGNUMWIRE SUTURE CARTRIDGE

    MDR report key: 2001347 · Received February 18, 2011

    Report

    Report Number
    2032380-2011-00009
    Event Type
    Other
    Date Received
    February 18, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K022229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS BEEN REQUESTED, BUT TO DATE HAS NOT BEEN PROVIDED. IT WAS REPORTED THAT THE DEVICE WILL BE RETURNED FOR INVESTIGATION. TO DATE THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION AND LOT HISTORY REVIEW ARE COMPLETE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED TO ARTHROCARE THAT A PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2011. AN OPUS SMARTSTITCH SUTURING DEVICE WITH MAGNUMWIRE SUTURE CARTRIDGE WAS USED. REPORTEDLY THE PLASTIC TIP OF THE SUTURE CARTRIDGE BROKE OFF IN THE PATIENT'S SHOULDER AND COULD NOT BE RETRIEVED; THEREFORE, THE PLASTIC TIP REMAINS IN THE DEPTHS OF THE SOFT TISSUE. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSTITCH WITH MAGNUMWIRE SUTURE CARTRIDGE ENDOSCOPE AND ACCESSORIES KOG ARTHROCARE CORPORATION 1010737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other