BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH, CURVED TIP

    MDR report key: 1896784 · Received November 11, 2010

    Report

    Report Number
    1220246-2010-00211
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    September 1, 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. THE EVALUATION REVEALED THAT ONE OF THE WINGS ON THE SHORT SUTURE CONSTRUCT IMPLANT IS BROKEN. SLIDING KNOT IS SLID VERY CLOSE TO THE SHORT SUTURE CONSTRUCT. SUTURE IS FRAYED NEXT TO THE LONG SUTURE CONSTRUCT AND SLIGHTLY FRAYED DISTAL TO THE SHORT SUTURE CONSTRUCT. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT.BASED ON THE INFORMATION PROVIDED AND DEVICE EVALUATION, THE MOST LIKELY CAUSE(S) OF THIS EVENT INCLUDES ENTANGLING THE SUTURE WHICH CAN CREATE ANOTHER KNOT WHILE DEPLOYING THE INSERTION SPEARS, INADVERTENT FRAYING OR NICKING THE SUTURE AND/OR AN IMPROPERLY TIED KNOT.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 DURING A REPAIR OF A MENISCAL TEAR, THE SLIDING KNOT COULD NOT BE MOVED.THE SUTURE IS VERY FRAYED. THE SECOND ANCHOR COULD NOT BE RETRIEVED ANYMORE, IT REMAINED IN THE MENISCUS. THE WING OF THE FIRST IMPLANT IS BROKEN, BUT THIS IMPLANT COULD BE RETRIEVED. 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. 351737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other