BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE

    MDR report key: 8539490 · Received April 23, 2019

    Report

    Report Number
    1017294-2019-00048
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 25, 2019
    Report Date
    May 23, 2019
    Manufacturer
    CONMED CORPORATION
    Product Code
    MBI
    UDI-DI
    10845854021651
    PMA / PMN Number
    K111779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING FIELDS: CORRECTED 510K FROM K11179 TO K111779. THE NARRATIVE SHOULD READ "A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 14 COMPLAINTS, REGARDING 16 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. (B)(4). IT WAS ORIGINALLY REPORTED AS " A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 14 COMPLAINTS, REGARDING 16 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. (B)(4). THE NUMBER OF SHIPPED UNITS WAS CORRECTED, HOWEVER THE OTHER INFORMATION REMAINS UNCHANGED AND CORRECT. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT THAT ONE OF THE DRIVER TIPS WAS BROKEN WAS CONFIRMED. VISUAL EXAMINATION FOUND SUTURE ANCHOR ASSEMBLY BROKEN OFF AT ONE OF THE TIPS. THE OTHER TIP WAS SLIGHTLY BENT. BROKEN PORTION WAS NOT RETURNED WITH PRODUCT FOR EVALUATION. IT IS SUSPECTED THAT THE USER APPLIED EXCESSIVE FORCE ON THE PRODUCT AND BROKE OFF THE TIP. THIS IS A TECHNIQUE-DEPENDENT DEVICE AND THE MOST LIKELY CAUSE OF THIS SUSPECTED FAILURE IS USER-RELATED. BROKEN TIP IS APPROXIMATELY 0.070 INCHES. EXAMINATION WAS PERFORMED PER DESIGN PRINT. CRITICAL DIMENSIONS WERE INSPECTED PER PRINT AND COULD NOT FIND ANY DISCREPANCIES. 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 WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A TWO-YEAR LOT HISTORY REVIEW SHOWS THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 14 COMPLAINTS, REGARDING 16 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 56,592 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 0.0003. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. CONMED ENCOURAGES THE INSPECTION AND/OR TEST OF ALL MEDICAL EQUIPMENT PRIOR TO USE TO ENSURE ALL DEVICES ARE FUNCTIONING AS EXPECTED. PER THE IFU, THE USER IS ALSO ADVISED TO 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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    ON BEHALF OF THE CUSTOMER, THE CONMED SALES REPRESENTATIVE REPORTED ISSUES WITH THE Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE #2 WHITE/BLUE HI-FI SUTURE, ITEM # Y1301, LOT # 989333 THAT OCCURRED (B)(6) 2019 AT CHIR. ZENTRUM DURING A LABRUM REFIXATION PROCEDURE INVOLVING A (B)(6) YEAR OLD MALE WEIGHING (B)(6) KG. IT WAS REPORTED "DURING DRIVING THE METAL PEAK OF THE ANCHOR WAS BROKEN AT THE FORK. THE METAL PIECE WAS REMOVED FROM THE PATIENT WITHOUT INJURY." IT IS INDICATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATE Y1301 BUT WITH A 30-MINUTE DELAY. ADDITIONAL INFORMATION OBTAINED INDICATES THAT THE ISSUE OCCURRED AT THE END OF THE PROCEDURE WHILE PLACING THE FIRST SUTURE ANCHOR. THE METAL PIECE WAS RETRIEVED WITH GRASPING FORCEPS AND THE PHYSICIAN CONFIRMED THAT ALL THE PIECES WERE REMOVED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE (THE FRAGMENTATION OF THE DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333896 Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED CORPORATION 989333 10845854021651

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR