BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENISCAL CINCH

    MDR report key: 1376466 · Received May 6, 2009

    Report

    Report Number
    1220246-2009-00057
    Event Type
    Other
    Date Received
    May 6, 2009
    Date of Event
    April 8, 2008
    Report Date
    April 10, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RECEIVED FOR EVALUATION; THE COMPLAINT WAS CONFIRMED. DEVICES RECEIVED WITH HANDPIECE SHAFT BROKEN AT THE WELD AND TROCAR #2 INTACT WITH NO ISSUES. VISUAL INSPECTION REVEALED THE BROKEN SHAFT SHOWS SIGNS OF WELDING. THE LARGER SHAFT'S ID IS DEFORMED FROM THE TOP END WHERE IT SHOWS SIGNS OF PRYING/LEVERAGING. THE MATERIAL WAS ANALYZED AND IT MEETS THE PRINT. 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 LEVERAGING/PRYING THE DEVICE DURING THE IMPLANTATION PROCEDURE. 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 AN ACL RECONSTRUCTION, THE #1 IMPLANT REMAINS IN THE PATIENT'S LEFT KNEE, INTACT AND UNSECURED. THE SURGEON WAS ABLE TO INSERT THE FIRST IMPLANT WITHOUT ISSUE; HOWEVER, WHEN SHE TRIED TO MOVE THE CANNULA TO THE SECOND INSERTION POINT THE SHEATH (CANNULA) BROKE IN HALF. THE SURGEON FELT THAT THE SPACE WAS MORE RIGID THAN USUAL (UP AGAINST BONE) WHEN SHE MOVED TO THE SECOND INSERTION POINT. THE CASE WAS COMPLETED WITH A COMPETITOR'S DEVICE. 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 219292

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR INFORMATION REQUESTED BUT NOT PROVIDED.