BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH, CURVED TIP

    MDR report key: 1896804 · Received November 11, 2010

    Report

    Report Number
    1220246-2010-00212
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, 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 RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. LONG SUTURE CONSTRUCT IS BROKEN OFF. THE SUTURE IS SEVERELY FRAYED WHERE THE LONG SUTURE CONSTRUCT BROKE OFF. IMPLANT ON THE SHORT SUTURE CONSTRUCT IS BROKEN OFF. SLIDING KNOT IS SLID VERY CLOSE TO THE SHORT SUTURE CONSTRUCT AND IS TIGHTLY KNOTTED. NO VISUAL NON-CONFORMANCE TO THE HANDPIECE. BASED ON THE INFORMATION PROVIDED AND DEVICE EVALUATION, THE MOST LIKELY CAUSE OF SUTURE FRAYING INCLUDES INADVERTENT FRAYING, NICKING OR CUTTING OF THE SUTURE WHILE ADVANCING THE INSERTION SPEARS AND/OR ADVANCING THE KNOT WITH A KNOT PUSHER WHILE THE SUTURE IS NOT IN-LINE WITH THE PUSHER. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE WAS ALREADY A LITTLE OUT SIDE DURING UNPACKAGING, HAD TO BE PUT IN THE CORRECT POSITION AGAIN BEFORE INSERTION. SUTURE IS FRAYED. SURGEON DID NOT TRY TO RETRIEVE THE BROKEN OFF PIECES. PIECES REMAIN IN THE PATIENT. NO 2ND SURGERY. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED AT THE TIME THIS EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCAL CINCH, CURVED TIP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 327025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other