BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONESCALPEL

    MDR report key: 14731610 · Received June 17, 2022

    Report

    Report Number
    14731610
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    March 29, 2022
    Report Date
    June 1, 2022
    Manufacturer
    MISONIX INC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A SPINE PROCEDURE, WE WERE USING THE MISONIX BONE SCALPEL (REF#110-31-110, LOT#203166) WHEN THE TIP OF THE BLADE ON THE SCALPEL BROKE OFF. THE TEAM WAS NOTIFIED IMMEDIATELY, AND THE TIP WAS SEARCHED FOR ON THE FIELD AND WITHIN THE WOUND. THE TIP WAS NOT RECOVERED FROM THE WOUND AND NOT FOUND ON THE FIELD. THE MD DECIDED TO CONTINUE WITH THE PROCEDURE. X-RAY WAS NOTIFIED UPON CLOSING AND A FLAT PLATE WAS ORDERED FOR THE PATIENT. THE RADIOLOGIST READ THE X-RAY AND THE PIECE WAS NOT DETECTED IN THE WOUND. THE MD CONTINUED TO CLOSE, AND THE CHART WAS CHARTED APPROPRIATELY UPON THIS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203142 BONESCALPEL INSTRUMENT, ULTRASONIC SURGICAL LFL MISONIX INC 110-31-110 203166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown