BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH, CURVED TIP

    MDR report key: 3020911 · Received March 26, 2013

    Report

    Report Number
    1220246-2013-00044
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS NOT CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS NOT CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. RETURNED DEVICES INCLUDE MENISCAL CINCH HAND PIECE, TROCARS #1 AND #2. THE SUTURE CONSTRUCT WAS NOT RETURNED. THERE ARE NO VISUAL NON-CONFORMANCES TO THE RETURNED COMPONENTS. THE COMPONENT SUTURE CONSTRUCT THAT WAS PART OF THE EVENT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE MOST LIKELY CAUSE OF THIS TYPE OF 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. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE 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 THE FIRST IMPLANT DEPLOYED CORRECTLY, HOWEVER, THE KNOT WOULD NOT SLIDE DOWN ONCE THE SECOND IMPLANT WAS IMPLANTED. THE SURGEON ELECTED TO FINISH THE CASE WITH A MENISCECTOMY. THE PEEK IMPLANTS WERE NOT RECOVERED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123122 MENISCAL CINCH, CURVED TIP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 433601

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other