BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENISCAL CINCH

    MDR report key: 1375640 · Received February 27, 2009

    Report

    Report Number
    1220246-2009-00018
    Event Type
    Other
    Date Received
    February 27, 2009
    Date of Event
    January 19, 2009
    Report Date
    February 2, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVAL BUT WAS NOT RETURNED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFO PROVIDED, THE MOST LIKELY CAUSE OF THE IMPLANT NOT COMING OUT OF THE CANNULA IS NOT FOLLOWING THE DEPLOYMENT SEQUENCE AS STATED IN THE SURGICAL TECHNIQUE GUIDES. 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 THE DEVICE IS RETURNED AND ADD'L RELEVANT INFO IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SURGEON CONVERTED TO A MENISCUS RESECTION. THREE REPAIR DEVICES WERE USED IN THE CASE. THE #2 IMPLANTS DID NOT COME OUT (OF THE CANNULA); THE HOSPITAL STAFF THREW THE ITEMS AWAY. ALL PARTS OF THE DEVICES WERE RETRIEVED FROM THE PT. THERE WAS A 45 MINUTE DELAY IN THE SURGERY. NO FURTHER PT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR IN RESPONSE TO F/U COMMUNICATION. NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCAL CINCH GAT ARTHREX, INC. NA 233382

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention INFO REQUESTED BUT NOT PROVIDED