BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPUS SMARTSTITCH M-CONNECTOR

    MDR report key: 1624756 · Received March 3, 2010

    Report

    Report Number
    2032380-2010-00006
    Event Type
    Other
    Date Received
    March 3, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 3, 2010
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    MFJ
    PMA / PMN Number
    K023843
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS WAS DISCARDED BY THE HEALTHCARE FACILITY AND IS NOT RETURNING TO ARTHROCARE FOR EVALUATION. ONCE A LOT HISTORY REVIEW IS COMPLETED, A FOLLOW-UP REPORT WILL BE PROVIDED. (B) (4). THREE OF THREE; CROSS-REFERENCE MDRS 2032380-2010-00004 AND 2032380-2010-00005.

    Description of Event or Problem · 1

    ON (B) (6) 2010, A PT UNDERWENT A ROTATOR CUFF SURGERY USING THREE OPUS SMARTSTITCH M-CONNECTORS. IN EACH CASE, WHEN THE DOCTOR DEPLOYED THE NEEDLES AND RETRACTED THEM, THE DEVICE FAILED TO GRAB THE SUTURE. ALTHOUGH TWO OF THE DEVICES WERE DISCARDED WITHOUT BEING INSPECTED, THE THIRD DEVICE WAS MISSING THE STAINLESS STEEL HOOK ON THE RIGHT NEEDLE AS NOTICED AT THE END OF SURGERY. THE TREATMENT TEAM WAS UNSURE IF THE SMALL TIP OF THE THIRD DEVICE WAS LEFT BEHIND IN THE PT AND IF THE OTHER TWO DISCARDED DEVICES MIGHT ALSO HAVE BEEN MISSING THEIR TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS SMARTSTITCH M-CONNECTOR ENDOSCOPE AND ACCESSORIES MFJ ARTHROCARE CORP. 1006746

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other