BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH, CURVED TIP

    MDR report key: 1970180 · Received January 25, 2011

    Report

    Report Number
    1220246-2011-00004
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 7, 2011
    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

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED, BUT NOT PROVIDED. 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. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE NOT ALLOWING THE TRAILING SUTURE TO REMAIN FREE AND UNOBSTRUCTED DURING IMPLANT INSERTION AND/OR BY NOT FOLLOWING THE DEPLOYMENT SEQUENCE AS OUTLINED IN THE SURGICAL TECHNIQUE GUIDES. PER THE DIRECTIONS FOR USE, THE USER IS INSTRUCTED TO PLACE DOWNWARD PRESSURE ON THE SHAFT OF TROCAR #2 WHERE IT EXITS THE DEPTH STOP. THIS WILL RELEASE THE TROCAR AND PLACE IT INTO POSITION FOR INSERTION; INSERT THE SECOND IMPLANT BY PUSHING TROCAR #2 UNTIL THE HANDLE HITS THE BACK OF THE DEPTH STOP. DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR, THE FIRST IMPLANT SEATED CORRECTLY, THE SECOND IMPLANT DEPLOYED TOO EARLY. SURGEON REMOVED AS MUCH OF IMPLANT(S) AS HE COULD. A SECOND ATTEMPT TO REPAIR MENISCUS RESULTED IN THE SAME RESULT. AFTER MULTIPLE ATTEMPTS, THE TISSUE WAS NOT VIABLE FOR ADDITIONAL IMPLANTS. THE MENISCAL REPAIR WAS UNSUCCESSFUL. THE SURGEON CONVERTED TO A MENISCECTOMY WHICH WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCAL CINCH, CURVED TIP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 277025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-4500 LOTS 340442 AND 324272