BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH, CURVED TIP

    MDR report key: 2013194 · Received March 10, 2011

    Report

    Report Number
    1220246-2011-00036
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 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 TYPICAL CAUSE(S) 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. 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 ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    THE FIST IMPLANT DEPLOYED SUCCESSFULLY ON ALL THREE CINCHES. HOWEVER, THE SECOND IMPLANT DID NOT DEPLOY. EITHER THE NEEDLE IS MISSING THE IMPLANT IN THE CANNULATION OR THE IMPLANT IS MISSING COMPLETELY. THE SURGEON WAS ABLE TO COMPLETE THE CASE BY DOING AN INSIDE OUT MENISCAL REPAIR USING A 2.0 SUTURE AND A MEDIAL INCISION. PATIENT ALSO HAD A PARTIAL MEDIAL MENISCECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCAL CINCH, CURVED TIP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 399967

    Patients

    Seq Age Sex Outcome Treatment
    1 Other