BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSTITCH SUTURING DEVICE

    MDR report key: 2537735 · Received March 21, 2012

    Report

    Report Number
    3006524618-2012-00127
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 23, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GAT
    PMA / PMN Number
    K042031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S AGE, GENDER AND WEIGHT WERE NOT AVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE REPORTER; THEREFORE NO MFG OR EXPIRATION DATE CAN BE PROVIDED. REFERENCE MFR REPORTS: 9019871-2012-00126, 9019871-2012-00128, 9019871-2012-00129, 9019871-2012-00130.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS PERFORMING AN ARTHROSCOPIC LABRAL REPAIR USING A SPEEDSTITCH SUTURING DEVICE AND SUTURE CARTRIDGES. THE PHYSICIAN ATTEMPTED TO PLACE A STITCH IN THE LABRUM BUT NOTICE THE SPEEDSTITCH SUTURING DEVICE WOULD NOT ENGAGE THE SUTURES (LOT: 1017977). A SECOND SUTURE CARTRIDGE (LOT: 1017977) WAS LOADED BUT THE PHYSICIAN EXPERIENCED THE SAME RESULTS. THE SUTURES WERE THEN REMOVED FROM THE FIRST SUTURING DEVICE AND RELOADED ONTO A NEW SUTURING DEVICE. AGAIN, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO PASS THE SUTURES; HOWEVER, THE SUTURING DEVICE FAILED TO ENGAGE AND PASS THE SUTURES. A THIRD SUTURE CARTRIDGE (LOT: 1021260) WERE OPENED AND LOADED ONTO THE SUTURING DEVICE. INITIALLY, THE SUTURES APPEARED TO ENGAGE BUT WHEN THE NEEDLE WAS DEPLOYED THE SUTURE CARTRIDGE CAME OFF THE SUTURING DEVICE AND LANDED WITHIN THE JOINT SPACE. AS THE PHYSICIAN ATTEMPTED TO RETRIEVE THE CARTRIDGE FROM THE JOINT, THE METAL HEAD OF THE SUTURE CARTRIDGE DISCONNECTED FROM THE PLASTIC TUBING. THE METAL HEAD AND PLASTIC TUBE WERE EVENTUALLY RETRIEVED FROM THE JOINT. ULTIMATELY, THE PHYSICIAN WAS ABLE TO COMPLETE THE REPAIR HOWEVER, DETAILS REGARDING THE PRODUCTS AND/OR TECHNIQUES USED WERE NOT AVAILABLE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDSTITCH SUTURING DEVICE SUTURE DEVICE; ENDOSCOPIC ACCESSORIES GAT ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R