BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR

    MDR report key: 6875484 · Received September 19, 2017

    Report

    Report Number
    1017294-2017-00085
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Date of Event
    July 25, 2017
    Report Date
    September 18, 2017
    Manufacturer
    CONMED CORPORATION
    Product Code
    MBI
    UDI-DI
    10845854021651
    PMA / PMN Number
    K111779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE Y-KNOT FLEX INSERTER IS NOT EXPECTED TO BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED AT THE USER FACILITIES AFTER THE SURGERY. WITHOUT THE ACTUAL DEVICE, AN EVALUATION COULD NOT BE PERFORMED AND THE ROOT CAUSE OF THE REPORTED TIP BREAKAGE THEREFORE COULD NOT BE DETERMINED. THIS LOT 830045 WAS MANUFACTURED ON 9MAY2017. THERE WERE NO ANOMALIES OR NON-CONFORMANCES NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED PROBLEM. OF THE LOT CONTAINING (B)(4) UNITS, THERE WERE NO OTHER SIMILAR COMPLAINTS FOR THIS ITEM AND LOT NUMBER COMBINATION. IN ADDITION, A 2-YEAR REVIEW OF PRODUCT HISTORY FOR THIS DEVICE FAMILY SHOWS A TOTAL OF (B)(4) REPORTS OF BREAKAGE WITH A QUANTITY OF (B)(4) INCLUDING THIS ONE. DURING THIS SAME 2-YEAR TIME FRAME, APPROXIMATELY (B)(4) UNITS WERE SOLD WORLDWIDE, MAKING THE OCCURRENCE RATE FOR THIS FAILURE MODE (B)(4) PERCENT. TO DATE, THERE HAVE BEEN NO PATIENT LONG TERM ADVERSE EFFECTS RESULTING FROM THIS TYPE OF INCIDENTS. THIS FAILURE MODE IS ADDRESSED IN THE RISK DOCUMENTS AND THE RISK HAS BEEN FOUND TO BE ACCEPTABLE. CONMED WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINT SYSTEM TO ENSURE PRODUCT SAFETY. THIS DEVICE 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 DRIVER TIP BREAKAGE AND INJURY TO THE PATIENT, THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING PRECAUTIONS: - 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. - AVOID LATERAL LOADING WHILE INSERTING Y-KNOT ANCHORS. - MAINTAIN PROPER ALIGNMENT DURING INSERTION OF ANCHORS AND DISENGAGEMENT OF DRIVERS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING USE OF THE Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR IN AN ARTHROSCOPIC BANKART PROCEDURE, THE TIP OF THE INSERTER FRACTURED WHILE THE SURGEON WAS INSERTING THE ANCHOR INTO THE BURR HOLE. THE REPORTER STATED THAT THE PATIENT'S BONE QUALITY WAS GOOD AND HARD. THE ANCHOR WAS PULLED OUT OF THE BURR HOLE AND THE PIECE OF THE INSERTER CAME OUT OF THE HOLE ALONG WITH THE ANCHOR. SUBSEQUENTLY, THE SURGEON USED AN ALTERNATIVE DEVICE TO COMPLETE THE SURGERY. THE PATIENT DID NOT SUFFER ANY REPORTED INJURIES. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656211 Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED CORPORATION 830045 10845854021651

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR