BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH

    MDR report key: 4251068 · Received November 14, 2014

    Report

    Report Number
    1220246-2014-00225
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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 WAS REQUESTED/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE TYPICAL 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. 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 THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE EXPECTED BUT NOT YET RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SECOND IMPLANT DID NOT FIRE. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. PROCEDURE WAS A LEFT KNEE ARTHROSCOPY AND MENISCUS REPAIR. THERE HAS BEEN NO FURTHER ISSUES REPORTED RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737266 MENISCAL CINCH SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 1140494

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other AR-4500, MENISCAL CINCH, LOT 570237.