BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROFRACTURE AWL, 90 DEGREE

    MDR report key: 4210786 · Received October 29, 2014

    Report

    Report Number
    1017294-2014-00049
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 6, 2014
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED RECEIVED THE DAMAGED MICROFRACTURE AWL, 90 DEGREE FOR EVALUATION ON (B)(6) 2014 AND CONFIRMED THE REPORTED PROBLEM OF TIP BREAKAGE. VISUAL EXAMINATION OF THE RETURNED INSTRUMENT FOUND THE TIP OF THE AWL HAD BROKEN OFF AND THE BROKEN PORTION/TIP WAS NOT RETURNED. THE QUALITY ENGINEER FURTHER EVALUATED THE RETURNED AWL, WHICH INDICATED THAT THE HARDNESS WAS WITHIN SPECIFICATIONS, AND THE BREAK OCCURRED AT ABOUT 45 DEGREE ANGLE. CONSIDERING THIS IS A 90 DEGREE AWL, THE MOST LIKELY CAUSE OF THE BREAKAGE IS DUE TO EXCESSIVE FORCE BEING APPLIED TO THE INSTRUMENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THIS LOT WAS MANUFACTURED ON (B)(6) 2014 IN A LOT OF 5 UNITS, WITH NO NOTED DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED BREAKAGE. A REVIEW OF THE COMPLAINT HISTORY SHOWED THERE WERE NO OTHER COMPLAINTS RECEIVED FOR THIS ITEM AND LOT NUMBER COMBINATION. THIS MICROFRACTURE AWL, 90 DEGREE IS A REUSABLE DEVICE INTENDED TO PREPHENATE CARTILAGE AND TISSUE SUCH AS MENISCUS AND IS NOT INTENDED FOR BONE. IN THIS INSTANCE, THE MOST PROBABLE CAUSE OF THE TIP BREAKAGE WAS DUE TO UNINTENTIONAL USER ERROR, WHICH IS MOST LIKELY ASSOCIATED WITH THE OFF-LABEL USE OF THE DEVICE ON BONE. IN ADDITION, THIS INSTRUMENT IS APPROXIMATELY 8 MONTHS OLD. AS WITH ALL SURGICAL INSTRUMENTS, OVER EXTENDED USE AND IMPROPER CARE AND HANDLING OF THE DEVICE, WEAR AND DAMAGE CAN OCCUR TO THIS INSTRUMENT CAUSING IT NOT TO PERFORM AT ITS OPTIMUM AND MAY CAUSE OR CONTRIBUTE TO THE TIP BREAKAGE. TO REDUCE THE RISK OF TIP BREAKAGE AND INJURY TO THE PATIENT, THE INSTRUCTION FOR USE (IFU) FOR THIS DEVICE PROVIDES THE FOLLOWING PRECAUTIONS: -INSPECT INSTRUMENT PRIOR TO USE TO ENSURE IT IS IN GOOD PHYSICAL CONDITION AND FUNCTIONS PROPERLY, THERE SHOULD BE NO LOOSE, BROKEN OR MISALIGNED PARTS. -DO NOT APPLY SIDE OR BENDING LOADS. APPLICATION OF SIDE OR BENDING LOADS MAY RESULT IN DEVICE BREAKAGE. -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. AN EDUCATION LETTER WILL BE SENT TO THE CUSTOMER WITH THE EVALUATION RESULTS AND TO HIGHLIGHT SOME IMPORTANT DIFFERENCES IN THE USAGE OF THE LIGHT AND HEAVY MICROFRACTURE AWLS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS MICROFRACTURE AWL, 90° IN A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2014, THE TIP OF THE AWL BROKE OFF WHILE BEING USED ON BONE. IT WAS FURTHER REPORTED THAT THE BREAKAGE OCCURRED WHEN THE SURGEON WAS HOLDING THE AWL AGAINST THE BONE AND THE ASSISTANT HAMMERED ON THE AWL HEAD WITH A SMALL MALLET. SUBSEQUENTLY, THE SURGEON ELECTED TO CREATE AN ADDITIONAL PORTAL TO SAFELY RETRIEVE THE BROKEN TIP. AS REPORTED, OTHER THAN A 15 MINUTE DELAY, THE PROCEDURE WAS OTHERWISE COMPLETED AS INTENDED WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY. FOLLOW-UP WITH THE USER FACILITY REVEALED THAT THE 34 YEARS OLD, MALE PATIENT IS RECOVERING WELL AND CURRENTLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693778 MICROFRACTURE AWL, 90 DEGREE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONMED LINVATEC 534809

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other