BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM SPARTAN PEEK SUTURE IMPLANT WITH MAGNUMWIRE

    MDR report key: 3240984 · Received July 17, 2013

    Report

    Report Number
    3006524618-2013-00293
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K110781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY ROTATOR CUFF REPAIR USING A 5.5MM SPARTAN PEEK SUTURE IMPLANT WITH MAGNUMWIRE, THE IMPLANT WAS INITIALLY INSERTED INTO VERY SOFT BONE. WHEN THE SURGEON ATTEMPTED TO SECURE THE IMPLANT, IT PULLED OUT OF THE BONE. THE SURGEON SWITCHED TO A COMPETITOR'S CORKSCREW ANCHOR, WHICH WAS IMPLANTED IN A NEW BONE HOLE. IN AN ATTEMPT TO COMPLETE THE PROCEDURE, THE SURGEON ASSESSED THAT AN ADDITIONAL IMPLANT WAS REQUIRED. ANOTHER NEW BONE HOLE WAS DRILLED INTO SOFT BONE, AND THE SURGEON TRIED ANOTHER 5.5MM SPARTAN PEEK SUTURE IMPLANT. WHEN THIS IMPLANT WAS INSERTED, THE ACTION OF SCREWING THE IMPLANT INTO THE BONE MADE THE HOLE LARGER THAN IT NEEDED TO BE, PREVENTING THE IMPLANT FROM BITING. THE ENLARGED HOLE ALLEGEDLY FORCED THE CORKSCREW ANCHOR OUT OF THE BONE. AFTER A 35 MINUTE SURGICAL DELAY, THE SURGEON CONVERTED THE PROCEDURE INTO MINI-OPEN. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332954 5.5MM SPARTAN PEEK SUTURE IMPLANT WITH MAGNUMWIRE FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD MBI ARTHROCARE CORPORATION 1021103

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other