BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH

    MDR report key: 4122471 · Received September 26, 2014

    Report

    Report Number
    1220246-2014-00172
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH, 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 INVOLVED IN THE EVENT WAS NOT RETURNED. THE COMPLAINT WAS NOT CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. 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 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 WITH BOTH DEVICES, THE FIRST IMPLANT FIRED BUT THE SECOND WAS OFF THE NEEDLE. THE FIRST IMPLANTS WERE REMOVED FROM THE PATIENT BUT THE PROCEDURE WAS CHANGED TO A MENISCECTOMY (SURGICAL INTERVENTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600915 MENISCAL CINCH SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 541196

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other