BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONIC CTRL SERRATED AGG KNIFE

    MDR report key: 4001096 · Received August 12, 2014

    Report

    Report Number
    0001811755-2014-02846
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SONIC CONTROL SERRATED AGG KNIFE BROKE OFF DURING THE COURSE OF A SPINE PROCEDURE AT THE USER FACILITY. IT WAS REPORTED THAT THE TIP FELL INTO THE SURGICAL SITE, BUT SURGEON WAS ABLE TO REMOVE THE PIECE USING FORCEPS. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. A BACKUP DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480358 SONIC CTRL SERRATED AGG KNIFE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1