BEUDAMED
    FDA Adverse Event Other Summary report: N

    KNOT PUSHER, SINGLE-HOLE

    MDR report key: 1202754 · Received October 10, 2008

    Report

    Report Number
    1220246-2008-00209
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUT SUTURE AND THE KNOT PUSHER ACCESSORY WERE BOTH RETURNED FOR EVAL. THE COMPLAINT WAS CONFIRMED. THE EVENT WAS DETERMINED TO HAVE BEEN CAUSED BY THE KNOT PUSHER. THE SUTURE WAS RECEIVED IN TWO PIECES; THE CUT AREA OF THE SUTURE WAS FRAYED AND NOT A CLEAN CUT. TESTING RESULTS FOR THE SUTURES MET ACCEPTANCE CRITERIA. THE RETURNED SUTURE WAS FUNCTION TESTED WITH THE KNOT PUSHER WHICH WAS ALSO RETURNED; THE KNOT PUSHER FRAYED AND CUT THE SUTURE DURING FUNCTION TESTING. THE KNOT PUSHER EVAL REVEALED A SHARP EDGE INSIDE THE HOLE AT THE DISTAL END. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE EVAL CONCLUSION WAS UNDETERMINED. THE REPORTED INSTRUMENT IS CURRENTLY FOUR YEARS OLD. AN INSTRUMENT OF THIS AGE HAS MOST LIKELY BEEN SUBJECT TO WEAR AND TEAR. AS STATED IN THE PRODUCT DFU-0023R14, G.2., "INSPECT THE INSTRUMENTS FOR DAMAGE PRIOR TO USE AND AT ALL STAGES OF HANDLING THEREAFTER." THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS MECHANICAL DAMAGE TO THE DEVICE, SUCH AS HITTING THE DEVICE WITH ANOTHER DEVICE, WHICH CAN CREATE SCRATCHES OR NICKS; NICKS ON THE KNOT-TYING SURFACE OF THE DEVICE CAN FRAY OR BREAK SUTURE. THE EVENT OF FIBERWIRE BREAKING WAS NOT A RESULT OF THE KNOT PUSHER DESIGN. THIS IS THE THIRD COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A KNOT PUSHER CUT A FIBERWIRE SUTURE IN TWO DURING A ROTATOR CUFF REPAIR CASE (RIGHT SHOULDER). THE SUTURE THAT WAS CUT WAS RETRIEVED. AN OPEN PROCEDURE WAS THEN PERFORMED TO COMPLETE THE CASE. FOLLOW-UP WITH THE REPORTER PROVIDED INFO THAT ANOTHER INCISION WAS NECESSARY FOR THE OPEN PROCEDURE; THE CASE WAS COMPLETED SUCCESSFULLY. THE DEPTH OF THE IMPLANT IMPLANTED WAS REPORTED AS FULLY SEATED. THE QUALITY OF PT BONE WAS REPORTED AS AVERAGE. NO FURTHER PT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNOT PUSHER, SINGLE-HOLE LXH ARTHREX, INC. NA 02045101

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other INFO REQUESTED BUT NOT PROVIDED.