BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSCREW 6.5MM IMPLANT

    MDR report key: 2622236 · Received May 30, 2012

    Report

    Report Number
    3006524618-2012-00530
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    April 27, 2012
    Report Date
    May 2, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HWC
    PMA / PMN Number
    K101448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT IDENTIFIER, AGE, WEIGHT AND GENDER WERE NOT AVAILABLE. REFERENCE MANUFACTURERS REPORT (S): 3006524618-2012-00531.

    Description of Event or Problem · 1

    DURING A ROTATOR CUFF REPAIR THE PHYSICIAN WAS UTILIZING A SPEEDSCREW 6.5MM IMPLANT. THE IMPLANT WAS FULLY INSERTED INTO THE PT'S BONE AND A SMARTSTITCH PERFECTPASSER (WHITE) MAGNUMWIRE SUTURE WAS THREADED THROUGH THE EYELETS OF THE DEVICE. UPON ATTEMPTING TO ROTATE THE ACTIVATION KNOB, THE SUTURE DID NOT ADVANCE THROUGH THE IMPLANT. A SECOND SPEEDSCREW 6.5MM IMPLANT WAS INSERTED INTO THE PT'S BONE AND A SMARTSTITCH PERFECTPASSER (CO-BRAID) MAGNUMWIRE SUTURE WAS THREADED THROUGH THE EYELETS. AGAIN, UPON ATTEMPTING TO ROTATE THE ACTIVATION KNOB, THE SUTURE DID NOT ADVANCE THROUGH THE IMPLANT. BOTH IMPLANTS WERE REMOVED FROM THE SURGICAL SITE. AN ADDITIONAL BONE HOLE WAS REQUIRED TO BE DRILLED AND A SPEEDSCREW 5.5MM IMPLANT AND SEVERAL SIDE BY SIDE SUTURES WERE PLACED TO COMPLETE THE REPAIR WITH A DELAY OF APPROXIMATELY 5 MINUTES. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDSCREW 6.5MM IMPLANT SCREW, FIXATION, BONE HWC ARTHROCARE CORPORATION W100233

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE, (B)(4)| SMARTSTITCH PERFECTPASSER (CO-BRAID) SUTURE| SMARTSTITCH PERFECTPASSER (WHITE) SUTURE CARTRIDGE| (B)(4)