BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH

    MDR report key: 7086015 · Received December 6, 2017

    Report

    Report Number
    1220246-2017-00461
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    November 16, 2017
    Report Date
    December 6, 2017
    Manufacturer
    ARTHREX INC.
    Product Code
    GAT
    UDI-DI
    00888867033535
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS IS ONE OF TWO SUBMISSIONS FOR THE SAME PATIENT EVENT. THE OTHER IS 1220246-2017-00460 ((B)(4)). THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO ARTHREX. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE CAUSE OF THE EVENT IS UNDETERMINED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION WITH MENISCAL REPAIR PROCEDURE, THE NEEDLE ON THE FIRST MENISCAL CINCH (LOT: 10138182, LINE (B)(4)) WENT IN AND THE FIRST IMPLANT WAS SUCCESSFULLY INSERTED AND IMPLANTED. AS THE SURGEON WAS TIGHTENING THE KNOT, THE SUTURE BROKE. THE SUTURE WAS REMOVED AND THE IMPLANTS STAYED IN THE PATIENT. THE SAME EXACT THING HAPPENED WITH TWO MORE MENISCAL CINCHES (LOT: F162047, LINE (B)(4), QTY:2). THE IMPLANTS WERE SUCCESSFULLY IMPLANTED AND THE SUTURE BROKE WHILE THE SURGEON WAS TIGHTENING THE KNOTS. THE IMPLANTS WERE LEFT IN THE PATIENT SAND ALL SUTURE WAS REMOVED. THE CASE WAS COMPLETED WITH A 4TH MENISCAL CINCH. PATIENT IS A MALE, (B)(6). FOLLOW UP INVESTIGATION: REP WHO WAS PRESENT AT TIME OF PROCEDURE STATED THAT A VISUAL INSPECTION OF THE MENISCAL CINCHES SHOWED NOTHING OUT OF THE ORDINARY. THE DEVICES WERE DISPOSED OF IN THE SHARPS CONTAINER PER HOSPITAL PROTOCOL AND WILL NOT BE RETURNED FOR EVALUATION. THE SUTURE BROKE WHILE TIGHTENING THE KNOT DOWN TO THE TISSUE. THIS WAS DONE BY THE SURGEON PULLING ON THE SUTURE BY HAND. NO KNOT PUSHER DEVICE WAS USED. SURGEON WOULD HAVE USED A 2-0 SUTURE CUTTER TO CUT THE KNOT WHEN TIGHTENED PROPERLY, BUT NEVER GOT TO THAT STEP AS THE SUTURE BROKE BEFORE NEEDING TO BE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867555 MENISCAL CINCH SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX INC. AR-4500 F162047 00888867033535

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other