BEUDAMED
    FDA Adverse Event Summary report: N

    MICROFRACTURE AWL, 90 DEGREE

    MDR report key: 3901619 · Received June 30, 2014

    Report

    Report Number
    1017294-2014-00025
    Date Received
    June 30, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED RECEIVED THE DAMAGED MICROFRACTURE AWL, 90 DEGREE FOR EVALUATION ON 13-JUN-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 WAS NOT RETURNED. THIS DEVICE WAS MANUFACTURED ON 19-OCT-2011. 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 TREPHINATE CARTILAGE AND TISSUE SUCH AS MENISCUS AND IS NOT INTENDED FOR BONE. IN THIS INSTANCE, THE EXACT CAUSE OF THE TIP BREAKAGE WAS UNABLE TO BE DETERMINED. HOWEVER, THE DAMAGED CONDITION OF THE RETURNED INSTRUMENT REVEALED THAT THE MOST LIKELY CAUSE OF THIS FAILURE IS USER-RELATED ASSOCIATED WITH EXTENSIVE USAGE OVER TIME AND/OR OFF-LABEL USE ON BONE. IN ADDITION, THIS INSTRUMENT HAS BEEN IN USE FOR OVER 2.5 YEARS. 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. - EXERCISE CARE IN THE USE OF THE DEVICE 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. 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 DEGREE IN A KNEE ARTHROSCOPIC PROCEDURE ON (B)(6) 2014, THE TIP OF THE AWL BROKE OFF IN THE SURGICAL SITE. THE BROKEN PIECE WAS RETRIEVED, THE SURGERY WENT ON AND COMPLETED AS INTENDED WITH NO FURTHER COMPLICATIONS, PATIENT INJURY OR SURGICAL DELAY. THE (B)(6), MALE PATIENT WAS DISCHARGED AS PER ROUTINE PROCEDURE FOR THIS TYPE OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379891 MICROFRACTURE AWL, 90 DEGREE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONMED LINVATEC 310490

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other