BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONIC CONTROL SERRATED KNIFE

    MDR report key: 3823355 · Received May 21, 2014

    Report

    Report Number
    0001811755-2014-01847
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION HAS BEEN COMPLETED. H3 OTHER TEXT : NOT YET RECEIVED BY MANUFACTURER

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SONIC CONTROL SERRATED KNIFE WAS BEING USED IN A POSTERIOR CERVICAL LAMINECTOMY FOR FINE BONE DISSECTION WHEN THE TIP BROKE OFF AND FELL INTO THE SURGICAL SITE. IT WAS CONFIRMED THAT THE TIP FRAGMENT WAS REMOVED SUCCESSFULLY WITHOUT HARM OR INJURY TO THE PATIENT. THERE WERE NO OTHER PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SONIC CONTROL SERRATED KNIFE WAS BEING USED IN A POSTERIOR CERVICAL LAMINECTOMY FOR FINE BONE DISSECTION WHEN THE TIP BROKE OFF AND FELL INTO THE SURGICAL SITE. IT WAS CONFIRMED THAT THE TIP FRAGMENT WAS REMOVED SUCCESSFULLY WITHOUT HARM OR INJURY TO THE PATIENT. THERE WERE NO OTHER PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303933 SONIC CONTROL SERRATED KNIFE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI 31609090244590QP

    Patients

    Seq Age Sex Outcome Treatment
    1