BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSHOT WITH Y-KNOT 1.8MM ALL-SUTURE ANCHOR

    MDR report key: 19266978 · Received May 8, 2024

    Report

    Report Number
    1017294-2024-00049
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 18, 2024
    Report Date
    June 27, 2024
    Manufacturer
    CONMED LARGO
    Product Code
    MBI
    UDI-DI
    30845854648982
    PMA / PMN Number
    K182446
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. H3 OTHER TEXT : DEVICE NOT YET RECEIVED.

    Additional Manufacturer Narrative · 0

    EVALUATION AND TESTING OF THE RETURNED USED ITEM FOUND THE ANCHOR ASSEMBLY BENT AND BROKEN ONE OF THE TIP FORKS. BROKEN ANCHOR TIP WAS NOT RETURNED FOR THE EVALUATION. ALSO, BOTH RIBBON AND SUTURE WERE FOUND ATTACHED. EXAMINATION PERFORMED PER PRINT, A14-040-328. A LIKELY CAUSE FOR DRIVER TIP BREAKAGE IS DUE TO THE APPLICATION OF EXCESSIVE AND / OR TORSIONAL FORCE. 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. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 2 COMPLAINTS, REGARDING 2 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT WHEN REMOVING TRUSHOT FROM PILOT HOLE, PULL DEVICE STRAIGHT OUT. DO NOT ROTATE OR OSCILLATE DEVICE ABOUT ITS AXIS OR BREAKAGE OF INSERTER TIP AND/OR ANCHOR MAY RESULT. 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. EXERCISE CARE IN THE USE OF THESE DEVICES TO MINIMIZE SIDE OR BENDING LOADS. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. AVOID UNINTENDED CONTACT WITH OTHER SURGICAL INSTRUMENTS DURING USE TO PREVENT DAMAGE OR BREAKAGE. AVOID LATERAL LOADING WHILE INSERTING THE ALL-SUTURE ANCHOR. INSPECT INSTRUMENTS AFTER USE TO ENSURE THEY HAVE NOT BEEN DAMAGED. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, Y18TN, TRUSHOT WITH Y-KNOT 1.8MM ALL-SUTURE ANCHOR, WAS BEING USED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿I HAVE A TRUSHOT THAT FAILED/PULLED OUT-BROKEN TIP. BICEPS TENODESIS ". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING FOUND THAT "ONE OF THE FORKS OF THE DEPLOYMENT TIP BROKE OFF, THE TIP WAS NOT FOUND OR RECOVERED. THE PATIENT WAS NOT HARMED." THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF TIP NOT RECOVERED OR FOUND.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, Y18TN, TRUSHOT WITH Y-KNOT 1.8MM ALL-SUTURE ANCHOR, WAS BEING USED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿I HAVE A TRUSHOT THAT FAILED/PULLED OUT-BROKEN TIP. BICEPS TENODESIS ". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING FOUND THAT "ONE OF THE FORKS OF THE DEPLOYMENT TIP BROKE OFF, THE TIP WAS NOT FOUND OR RECOVERED. THE PATIENT WAS NOT HARMED." THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF TIP NOT RECOVERED OR FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757794 TRUSHOT WITH Y-KNOT 1.8MM ALL-SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED LARGO 1352845 30845854648982

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other