BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE

    MDR report key: 25050243 · Received April 30, 2026

    Report

    Report Number
    2435119-2026-00009
    Event Type
    Injury
    Date Received
    April 30, 2026
    Report Date
    April 19, 2026
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K070313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON MARCH 20, 2026, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLES (PART NUMBER MXB-B1, LOT NUMBER 243116) THAT OCCURRED DURING A PROCEDURE IN 2025. THE DAY AND MONTH OF THE PROCEDURE WAS NOT REPORTED. SPECIFICALLY, THE REPORTER INDICATED THAT "THE SURGICAL TEAM REPORTED MULTIPLE OVERHEATING EVENTS DURING A SINGLE PROCEDURE, RESULTING IN BLADE BREAKAGE AND THE SYSTEM REACHING ITS LIMITS." FURTHERMORE, "IT APPEARS THAT THE PATIENT SUSTAINED A MINOR BURN." PERMANENT IMPAIRMENT TO BODY STRUCTURE OR BODY FUNCTION WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597992 BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE 20MM, UNILATERAL SERRATIONS DISPOSABLE LFL MISONIX, INC. MXB-B1 243116

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other