BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMP SWVLK SP, 4.75X24.5MM

    MDR report key: 9069854 · Received September 16, 2019

    Report

    Report Number
    1220246-2019-01315
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    May 1, 2018
    Report Date
    September 16, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867026865
    PMA / PMN Number
    K151342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD UNDERGONE SURGERY ON (B)(6) 2018 FOR ROTATOR CUFF AND TENDON REPAIRS. ACCORDING TO THE IMPLANT LOG PROVIDED THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: AR-2324BCCT, BIOCOMPOSITE SWIVELOCK C (QTY 1, LOT # F171853) AR-2324BCM, BIOCOMPOSITE SWIVELOCK SP (QTY 2, LOT # F158844). ACCORDING TO THE OPERATIVE REPORT, THE SURGEON IMPLANTED TWO (2) ARTHREX SWIVELOCK® ANCHORS AT THE JUNCTION OF THE ARTICULAR CARTILAGE AND THE GREATER TUBEROSITY. THE ARTHREX FIBERTAPE WAS THEN PASSED THROUGH THE TORN ROTATOR CUFF, CRISSCROSSED, AND SECURED TO BONE WITH TWO (2) LATERAL ARTHREX SUTURE ANCHORS. THIS CREATED CLOSURE OF THE TENDON BACK DOWN TO BONE. ALTHOUGH THE OPERATIVE REPORT NOTED THAT A TOTAL OF FOUR (4) ARTHREX SUTURE ANCHORS WERE IMPLANTED, THE IMPLANT LOG SHOWS ONLY THREE (3) ANCHORS WERE USED. APPROXIMATELY TWO WEEK POST-OP THE PATIENT HAD AN X-RAY TAKEN AND AT THE TIME OF THE X-RAY THE PATIENT WAS REPORTING PAIN IN THE LEFT SHOULDER. THE X-RAY FINDINGS INDICATED ONE OF THE SURGICAL ANCHORS WAS NOTED TO PROJECT WITHIN THE SOFT TISSUES ON THE AP VIEW. THE PATIENT'S (B)(6) 2018 PHYSICAL THERAPY RECORDS NOTE THAT THE SURGEON'S NURSE ORDERED ALL THERAPY TO BE HELD UNTIL THE PATIENT COULD GET AN MRI. RECORDS NOTED THAT IT WAS BELIEVED THE PATIENT'S ANCHOR MAY HAVE COME LOOSE REQUIRING A POSSIBLE ADDITIONAL SURGERY. ON (B)(6) 2018 THE PATIENT UNDERWENT A SECOND SURGERY. THE PROCEDURE WAS PERFORMED AS A REMOVAL ONLY AND NO REVISION TO THE TENDON WAS REQUIRED. THE OPERATIVE REPORT NOTED THAT AN ARTHREX SWIVELOCK ANCHOR HAD BROKEN. THE BROKEN FRAGMENT AND THE REMAINING PIECE OF ANCHOR IN BONE WERE BOTH REMOVED FROM THE PATIENT. THE REPORT NOTED THAT THE PATIENT¿S ROTATOR CUFF WAS PRISTINE WITH NO SIGN OF A RECURRENT TEAR. THE REMOVAL OPERATIVE REPORT ALSO NOTED THAT THE PREVIOUS FIBERTAPE SUTURES WERE SEEN, HOWEVER, THERE WAS NO MENTION OF THE SUTURES BEING REMOVED. IT IS UNKNOWN WHICH OF THE THREE ORIGINAL SWIVELOCK ANCHORS WAS THE ONE WHICH BROKE AND WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867985 BIO-COMP SWVLK SP, 4.75X24.5MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM F158844 00888867026865

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other