BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-KNOT ALL SUTURE ANCHOR

    MDR report key: 3180464 · Received June 20, 2013

    Report

    Report Number
    1017294-2013-00023
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CONMED LINVATEC
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION AND VISUAL INSPECTION OF THE RETURNED Y-KNOT ALL SUTURE ANCHOR DRIVER FOUND THE TIP OF THE INSERTER WAS BROKEN OFF. FURTHER ANALYSIS FROM THE RESEARCH AND DEVELOPMENT ENGINEER REVEALED THE OVERALL LENGTH OF THE DRIVER/INSERTER WAS WITHIN SPECIFICATIONS, AND CONCLUDED THAT A POSSIBLE CAUSE OF THIS FAILURE IS INSERTING THE DRIVER TOO FAR INTO THE PILOT HOLE. IT IS BELIEVED THAT THE MOST LIKELY CAUSE OF THE DRIVER BREAKAGE IS USER RELATED, AND A PROBABLE RESULT OF MISUSE. EXCESSIVE FORCE WAS MOST LIKELY APPLIED DURING MALLETING (INDICATIVE OF PROXIMAL MATERIAL DISPLACEMENT EXHIBITED ON THE BROKEN PORTION OF THE DRIVER/INSERTER), THEREBY SENDING THE DRIVER, ANCHOR, AND DRILL GUIDE FURTHER INTO THE BONE THAN DESIGNED. (B)(4). THERE WERE NO ANOMALIES OR NONCONFORMANCES NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED PROBLEM. THERE IS ONE OTHER COMPLAINT FOR "SUTURE BREAKAGE" 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 IS A NEWLY RELEASED DEVICE, WHICH 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 BREAKAGE AND INJURY TO THE PATIENT, THE PRODUCT INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING CAUTIONS: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS HF13A Y-KNOT ALL-SUTURE ANCHOR IN A SHOULDER (BANKART REPAIR) PROCEDURE; WHILE INSERTING THE SECOND ANCHOR, A SMALL PIECE OF METAL TIP BROKE OFF OF THE INSERTER AND WAS LEFT INSIDE THE PILOT HOLE. AS REPORTED, THE ATTEMPT TO RETRIEVE THE BROKEN TIP WAS UNSUCCESSFUL, AS THE BROKEN FRAGMENT WAS DEEP INSIDE THE BONE AND WAS UNABLE TO BE REMOVED. THE SURGEON OPTED TO IMPLANT AND SECURE ANOTHER Y-KNOT ALL SUTURE ANCHOR ON TOP OF THE METAL FRAGMENT USING THE SAME PILOT HOLE. OTHER THAN A 20 MINUTE DELAY IN TRYING TO REMOVE THE METAL FRAGMENT, THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATION OR PATIENT INJURY. ADDITIONALLY, FOLLOW-UP WITH THE INTERNATIONAL AFFILIATE REVEALED THAT THE SURGEON DID NOT FEEL THE INCIDENT WAS OF MUCH CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280636 Y-KNOT ALL SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED LINVATEC HF13A 427302

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other