BEUDAMED
    FDA Adverse Event Summary report: N

    Y-KNOT FLEX HIP 1.3MM ALL SUTURE ANCHOR WITH ONE #2 WHITE/BLACK (5METRIC) HI-FI

    MDR report key: 4844209 · Received June 15, 2015

    Report

    Report Number
    1017294-2015-00026
    Date Received
    June 15, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    CONMED LINVATEC
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE Y-KNOT FLEX INSERTER IS NOT EXPECTED FOR EVALUATION AS IT WAS DISCARDED AT THE USER FACILITY. WITHOUT THE ACTUAL DEVICE AN EVALUATION COULD NOT BE PERFORMED, THE ROOT CAUSE OF THE BREAKAGE COULD NOT BE DETERMINED AND THE INCIDENT COULD NOT BE VERIFIED. EVALUATION OF SIMILAR COMPLAINTS 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. THIS DEVICE (UNIQUE IDENTIFIER (UDI) #(B)(4) WAS MANUFACTURED ON 31-MAR-2015 IN A LOT OF (B)(4) UNITS. THERE WERE NO ANOMALIES OR NON-CONFORMANCES NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. NO OTHER COMPLAINT HAS BEEN RECEIVED FOR THIS ITEM AND LOT NUMBER COMBINATION. THIS FAILURE MODE IS ADDRESSED IN THE DFMEA, AND THE SAFETY RISK HAS BEEN FOUND TO BE ACCEPTABLE. THIS DEVICE IS 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. DEVICE WAS DISCARDED AT USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC HIP PROCEDURE ON (B)(6) 2015, THE SURGEON DRILLED INTO THE RIM OF THE ACETABULUM THEN INSERTED THE Y-KNOT FLEX HIP 1.3MM ALL SUTURE ANCHOR INTO THE DRILL GUIDE. A MALLET WAS USED TO DRIVE THE ANCHOR INTO THE PILOT HOLE AND ON THE LAST TAP OF THE MALLET A TINE BROKE OFF FROM THE MOST DISTAL END OF THE DRIVER. FLUOROSCOPY WAS BROUGHT IN AND USED TO CONFIRM THE TINE WAS STILL LOCATED IN THE ACETABULUM. THE DOCTOR ELECTED TO LEAVE THE TINE IN THE ACETABULUM AND COMPLETE THE SURGERY USING ANOTHER LIKE ANCHOR. OTHER THAN A 30 MINUTE DELAY THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THE (B)(6) YEAR OLD, FEMALE PATIENT WAS DISCHARGED PER ROUTINE PROCEDURE. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION NOR HAS THERE BEEN ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388104 Y-KNOT FLEX HIP 1.3MM ALL SUTURE ANCHOR WITH ONE #2 WHITE/BLACK (5METRIC) HI-FI FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED LINVATEC 636257

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other