BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-KNOT ALL-SUTURE ANCHOR WITH ONE #2 2 BLUE

    MDR report key: 3181730 · Received June 21, 2013

    Report

    Report Number
    1017294-2013-00025
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    CONMED LINVATEC
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED Y-KNOT ALL SUTURE ANCHOR DRIVER AND ITS BROKEN TIP ARE NOT EXPECTED FOR EVALUATION, AS BOTH WERE DISCARDED AT THE USER FACILITY. WITHOUT THE ACTUAL PRODUCT, AN EVALUATION COULD NOT BE PERFORMED AND THE CAUSE OF THE REPORTED FAILURE WAS UNABLE TO BE DETERMINED. EVALUATION OF SIMILAR COMPLAINT REVEALED A POSSIBLE CAUSE OF THIS FAILURE IS INSERTING THE DRIVER TOO FAR INTO THE PILOT HOLE. THIS CAN OCCUR, IF EXCESSIVE FORCE WAS APPLIED DURING MALLETING THEREBY SENDING THE DRIVER, ANCHOR, AND DRILL GUIDE FURTHER INTO THE BONE THAN DESIGNED. BASED ON THIS FINDING, IT IS BELIEVED THAT THE MOST LIKELY CAUSE OF THE DRIVER BREAKAGE IS USER RELATED, AND A PROBABLE RESULT OF MISUSE. THIS DEVICE WAS MANUFACTURED ON DECEMBER 13, 2013, IN A LOT OF 100 UNITS. THERE WERE NO ANOMALIES OR NONCONFORMANCE NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED PROBLEM. THERE ARE THREE OTHER COMPLAINTS FOR THIS ITEM AND LOT NUMBER. NONE ARE FOR THIS FAILURE MODE. THIS FAILURE MODE IS ADDRESSED IN THE (B)(4), AND THE SAFETY RISK HAS BEEN FOUND TO BE ACCEPTABLE. THIS IS A NEWLY RELEASED DEVICE, WHICH IS VERY TECHNIQUE DEPENDENT. PREOPERATIVE AND OPERATING PROCEDURES, INCLUDING KNOWLEDGE OF SURGICAL TECHNIQUES AND PROPER SELECTION AND PLACEMENT OF THE IMPLANT ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THIS DEVICE. TO REDUCE THE RISK OF BREAKAGE AND INJURY TO THE PATIENT, THE PRODUCT INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING CAUTIONS: EXERCISE CARE IN THE USE OF THE DEVICE TO MINIMIZE SIDE AND/OR BENDING LOADS. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. DEVICE WAS DISCARDED AT FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THE Y-KNOT ALL SUTURE ANCHOR AND ITS DISPOSABLE DRIVER/INSERTER IN A SHOULDER ARTHROSCOPY ON (B)(6) 2013, THE METAL TIP ON THE INSERTER BROKE OFF. THE SURGEON BELIEVED THE BROKEN TIP WAS REMOVED VIA SUCTION. NONETHELESS, X-RAY WAS PERFORMED AND CONFIRMED THAT THERE WAS NO BROKEN METAL LEFT IN THE JOINT. THE CASE WENT ON AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY. THE PATIENT WAS DISCHARGED AS PER NORMAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281685 Y-KNOT ALL-SUTURE ANCHOR WITH ONE #2 2 BLUE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED LINVATEC 420044

    Patients

    Seq Age Sex Outcome Treatment
    1 Other