BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONIC CTRL SERRATED AGG KNIFE

    MDR report key: 3185406 · Received June 24, 2013

    Report

    Report Number
    0001811755-2013-01451
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 24, 2013
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED. DEVICE NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE END OF THE TIP BREAKING OFF CAUSING A HIGH PITCH SOUND WAS DUPLICATED AND CONFIRMED. DURING EVALUATION THE DEVICE WAS VISUALLY INSPECTED TO HAVE A DIFFERENT COSMETIC FINISH ON THE SURFACE AND THERE WAS VARIABILITY IN THE WIDTH OF THE KNIFE. DURING FUNCTIONAL EVALUATION USING AN EXAMPLE TIP, THE TIP OF THE KNIFE BROKE OFF USING HARD CUTTING AND NO IRRIGATION SLEEVE. BASED ENGINEERING EVALUATION AND SUBJECT MATTER EXPERT CONSULTATION THE VARIABILITY IN THE WIDTH OF THE KNIFE AND LACK OF IRRIGATION CAN INDUCE A FLEXURAL MODE CAUSING IT TO BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SONIC CTRL SERRATED AGG KNIFE WAS BEING DEMONSTRATED BY A MANUFACTURER'S SALES REPRESENTATIVE WHEN THE TIP BROKE OFF ON THE END OF THE DEVICE. THE REPRESENTATIVE OPERATED THE DEVICE WITH NO TIP COVER FOR THE PURPOSE OF EXPLAINING HOW THE PRODUCT FUNCTIONS. INSTRUCTIONS WOULD INDICATE TO A HEALTH PROFESSIONAL NOT TO USE THE DEVICE WITHOUT A TIP COVER. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SONIC CTRL SERRATED AGG KNIFE WAS BEING DEMONSTRATED BY A MANUFACTURER'S SALES REPRESENTATIVE WHEN THE TIP BROKE OFF ON THE END OF THE DEVICE. THE REPRESENTATIVE OPERATED THE DEVICE WITH NO TIP COVER FOR THE PURPOSE OF EXPLAINING HOW THE PRODUCT FUNCTIONS. INSTRUCTIONS WOULD INDICATE TO A HEALTH PROFESSIONAL NOT TO USE THE DEVICE WITHOUT A TIP COVER. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284798 SONIC CTRL SERRATED AGG KNIFE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI UNKNOWN- PACKAGE DISCARDED.

    Patients

    Seq Age Sex Outcome Treatment
    1