BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENISCAL CINCH

    MDR report key: 1353490 · Received March 24, 2009

    Report

    Report Number
    1220246-2009-00028
    Event Type
    Other
    Date Received
    March 24, 2009
    Date of Event
    February 26, 2009
    Report Date
    February 26, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RECEIVED FOR EVALUATION; THE COMPLAINT WAS CONFIRMED. DEVICES RECEIVED; 6 HAND PIECES, 6 #1 TROCARS, 6 #2 TROCARS, AND ONE SUTURE. VISUAL INSPECTION REVEALED THE SUTURE IS BROKEN; APPROXIMATELY 12" OUT OF THE 38" SUTURE WAS RECEIVED. SUTURE KNOT PULL TEST WAS PERFORMED ON THE RETURNED SUTURE AND MEETS ALL ACCEPTANCE CRITERIA. THE HAND PIECES AND TROCARS VISUALLY, DIMENSIONALLY, AND FUNCTIONALLY MEET SPECIFICATIONS. THE POTENTIAL CAUSES OF THIS COMPLAINT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED AND DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS NOT FOLLOWING PROPER ORDER OF SURGICAL STEPS AS STATED IN THE SURGICAL TECHNIQUE GUIDES OR USING TOO MUCH FORCE WHEN TENSIONING THE SUTURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCL/MCL MENISCAL REPAIR, THREE IMPLANTS WERE PARTIALLY SECURED. THE SURGEON WAS HAVING TROUBLE CINCHING THE SECOND KNOT AND CUTTING THE SUTURE ON THE SECOND IMPLANTS. THE SURGEON CONVERTED FROM LAPAROSCOPIC TO AN OPEN PROCEDURE, IN AN ATTEMPT TO RETRIEVE THE IMPLANTS. THE CASE WAS SUCCESSFULLY COMPLETED WITH A FIFTH AND SIXTH IMPLANT FROM THE SAME LOT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCAL CINCH GAT ARTHREX, INC. NA 248201

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention INFORMATION REQUESTED BUT NOT PROVIDED