BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH, CURVED TIP

    MDR report key: 1920676 · Received December 13, 2010

    Report

    Report Number
    1220246-2010-00248
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    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. 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 REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE TYPICAL CAUSE OF THIS EVENT INCLUDES ENTANGLING THE SUTURE WHICH CAN CREATE ANOTHER KNOT WHILE DEPLOYING THE INSERTION SPEARS, INADVERTENT FRAYING OR NICKING THE SUTURE AND/OR AN IMPROPERLY TIED KNOT. ON THE PACKAGE, THERE IS A LABEL INSTRUCTING THE USER AS FOLLOWS: IF RESISTANCE IS FELT DURING IMPLANT INSERTION, ADVANCE TROCAR TO DEPTH STOP AND ROTATE TROCARS BACK AND FORTH WITH CONTROLLED PRESSURE. THIS WILL AVOID DAMAGING THE IMPLANTS. TO AVOID PREMATURE TENSION TO CONSTRUCT DO NOT PULL EXTERNAL SUTURE BEFORE RELEASING TROCAR #2. DO NOT TRAP EXTERNAL SUTURE AGAINST HANDLE. AFTER IMPLANTING #1, DO NOT MOVE DEVICE BEFORE RELEASING #2. 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. REMAINS IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REPAIR OF A MENISCAL TEAR, SURGEON WAS HAVING DIFFICULTY. THE KNOT WOULD NOT SLIDE EASILY AND WHEN KNOT PUSHER WAS PLACED ON SUTURE, SUTURE BROKE. IMPLANT WAS LEFT IN CAPSULE,SUTURE WAS REMOVED. SECOND IMPLANT WAS SLIDING DOWN SHAFT. IT FELL-OFF NEEDLE AND END OF NEEDLE WAS EMPTY. THE IMPLANT WAS LEFT IN CAPSULE, SUTURE WAS REMOVED, AND A THIRD IMPLANT WAS USED TO COMPLETE THE MENISCUS REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCAL CINCH, CURVED TIP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 394861

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other AR-4500