BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH, CURVED TIP

    MDR report key: 2001446 · Received February 25, 2011

    Report

    Report Number
    1220246-2011-00028
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    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 MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT IS USE OF EXCESSIVE PUSHING FORCE WHEN INSERTING THE SPEAR INTO THE MENISCUS AND NOT USING THE TECHNIQUE OF ROTATING/TWISTING THE SPEAR DURING INSERTION WHICH CAN CAUSE THE DISTAL PORTION OF THE IMPLANT TO PEEL BACK AND BREAK OFF. THE PRODUCT DIRECTIONS FOR USE (DFU-0156) WARNS AGAINST THE USE OF EXCESSIVE FORCE; SLIGHT ROTATION OF THE SPEAR MAY EASE DEPLOYMENT OF THE IMPLANT. ROTATION OF THE HANDLE SHOULD BE AVOIDED WHEN PUSHING THE KNOT AND CUTTING THE SUTURE. THE SURGICAL TECHNIQUE CONTAINS THE FOLLOWING NOTES: NOTE: IF RESISTANCE IS ENCOUNTERED DURING INSERTION OF THE IMPLANT, ROTATE TROCAR BACK AND FORTH APPROXIMATELY 90 DEGREES WHILE PUSHING FORWARD IN A CONTROLLED FASHION. THIS WILL HELP THE IMPLANT MOVE THROUGH THE MENISCAL TISSUE. 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. DEVICE DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REPAIR OF A MENISCAL TEAR, 2ND IMPLANT SPILT IN HALF ON INSERTION. FIRST IMPLANT INSERTED WITH NO PROBLEM THE SECOND ONE SURGEON FELT A SLIGHT RESISTANCE AS HE TRIED TO ADVANCE THE NEEDLE. HE PULLED BACK TO FIND THE IMPLANT WAS IN TWO PIECES. HE CUT THE SUTURES AND REMOVED THE IMPLANT, BUT LEFT THE FIRST ONE IN-PLACE. 2ND CINCH WAS USED TO COMPLETE THE CASE. MENISCAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCAL CINCH, CURVED TIP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 380709

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other AR-4500