BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH, CURVED TIP

    MDR report key: 2894031 · Received January 3, 2013

    Report

    Report Number
    1220246-2012-00262
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NO PROBLEM FOUND WITH THE RETURNED DEVICE ONCE THE IMPLANT IS LOADED ONTO THE 1ST TROCAR. DEVICE FUNCTIONS AS REQUIRED AND THERE ARE NO FRAYING/CUT SUTURES. DEVICE WAS FUNCTION TESTED WITH THE KNOT PUSHER (AR-4515) AND SUTURE CONSTRUCT AND DEVICES WERE OBSERVED TO FUNCTION AS DESIGNED. THE CAUSE OF THE COMPLAINT IS UNKNOWN. 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 KNOT PUSHER CUT THE SUTURE PRIOR TO THE CINCH. THE SUTURE WAS REMOVED FROM THE PATIENT; THE IMPLANTS FROM THIS MENISCAL CINCH WERE NOT RETRIEVED. THEY USED ANOTHER AR-4500 TO FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2940 MENISCAL CINCH, CURVED TIP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 405405

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other AR-4515, KNOT PUSHER SUTURE CUTTER, LOT # UNKNOWN