BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR

    MDR report key: 18091524 · Received November 8, 2023

    Report

    Report Number
    1017294-2023-00102
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    October 11, 2023
    Report Date
    December 18, 2023
    Manufacturer
    CONMED LARGO
    Product Code
    MBI
    UDI-DI
    10845854021651
    PMA / PMN Number
    K111779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, A DEVICE MALFUNCTION CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT PREOPERATIVE AND OPERATING PROCEDURES, INCLUDING KNOWLEDGE OF SURGICAL TECHNIQUES AND PROPER SELECTION AND PLACEMENT OF IMPLANTS ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THESE DEVICES. SURGEON MUST CHOOSE PROPER IMPLANT SIZE BASED ON SPECIFIC PROCEDURE AND PATIENT HISTORY. INSPECT INSTRUMENTS PRIOR TO USE TO ENSURE THEY ARE IN GOOD PHYSICAL CONDITION AND FUNCTION PROPERLY. THERE SHOULD BE NO LOOSE, BROKEN OR MISALIGNED PARTS. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR, LOT NUMBER 1225797 OR 1232489 DEVICE WAS BEING USED DURING A SHOULDER LABRUM ANNULOPLASTY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED Y-KNOT FLEX WAS BROKEN DURING THE SURGERY. Y1301 WAS USED IN LABRUMPLASTY. THE FACILITY INSERTED IT INTO THE GLENOID FOSSA AS USUAL, AND WHEN THEY CHECKED THE TIP THAT CAME OUT, THEY FOUND THAT IT WAS BROKEN. THE SURGERY WAS COMPLETED WITHOUT REMOVING THE BROKEN PIECE. THERE ARE NO PLANS TO REMOVE IT IN THE FUTURE. "FURTHER ASSESSMENT QUESTIONING CONFIRMED THAT THERE ARE NO PLANS FOR REMOVAL OF THE FRAGMENTED DEVICE." THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS "UNKNOWN". THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THE FACILITY CANNOT CONFIRM WHICH LOT NUMBER WAS USED DURING THIS PROCEDURE. THIS REPORT SHALL BE WRITTEN AGAINST LOT NUMBER 1232489. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT RETAINING A FOREIGN BODY.

    Description of Event or Problem · 0

    CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR, LOT NUMBER 1225797 OR 1232489 DEVICE WAS BEING USED DURING A SHOULDER LABRUM ANNULOPLASTY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿Y-KNOT FLEX WAS BROKEN DURING THE SURGERY. Y1301 WAS USED IN LABRUMPLASTY. THE FACILITY INSERTED IT INTO THE GLENOID FOSSA AS USUAL, AND WHEN THEY CHECKED THE TIP THAT CAME OUT, THEY FOUND THAT IT WAS BROKEN. THE SURGERY WAS COMPLETED WITHOUT REMOVING THE BROKEN PIECE. THERE ARE NO PLANS TO REMOVE IT IN THE FUTURE.¿. FURTHER ASSESSMENT QUESTIONING CONFIRMED THAT THERE ARE NO PLANS FOR REMOVAL OF THE FRAGMENTED DEVICE.¿. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿UNKNOWN¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THE FACILITY CANNOT CONFIRM WHICH LOT NUMBER WAS USED DURING THIS PROCEDURE. THIS REPORT SHALL BE WRITTEN AGAINST LOT NUMBER 1232489. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT RETAINING A FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923012 Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED LARGO 1232489 10845854021651

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other