BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH, CURVED TIP

    MDR report key: 1990377 · Received February 15, 2011

    Report

    Report Number
    1220246-2011-00014
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. TWO DEVICES RETURNED. ONE DEVICE WAS IN ITS ORIGINAL PACKAGING. DEVICE WAS FUNCTION TESTED AND FUNCTIONED PROPERLY. ON THE SECOND DEVICE ONLY THE TROCARS AND THE HANDPIECE RETURNED. THERE IS NO VISUAL NONCONFORMANCE ON THESE DEVICES. THE TYPICAL CAUSE OF THIS TYPE OF EVENT IS NOT ALLOWING THE TRAILING SUTURE TO REMAIN FREE AND UNOBSTRUCTED DURING IMPLANT INSERTION OR THE USER NOT FOLLOWING THE DEPLOYMENT SEQUENCE AS STATED IN THE SURGICAL TECHNIQUE GUIDES. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE SECOND 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 A REPAIR OF A MENISCAL TEAR, SURGEON HAD PROBLEMS DEPLOYING THE IMPLANTS AFTER 3 ATTEMPTS. SURGEON ABANDONED THE ARTHREX DEVICES AND OPTED FOR AN INSIDE OUT TECHNIQUE WITH NEEDLES AND SUTURE TO COMPLETE THE CASE BY MAKING A SECOND SMALL INCISION TO SECURE THE MENISCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCAL CINCH, CURVED TIP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 402922

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other AR-4500 LOTS 383294, 405402, 399964