BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT

    MDR report key: 20908785 · Received December 11, 2024

    Report

    Report Number
    2435119-2024-00049
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 11, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K231117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 11, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER: 110-31-1120, LOT NUMBER: 243238) THAT OCCURRED ON NOVEMBER 08, 2024, DURING A BILATERAL TMJ REPLACEMENT (OMFS). SPECIFICALLY, IT WAS REPORTED THAT "THE SURGEON ACCIDENTALLY STEPPED ON THE FOOTPEDAL AND SOMEHOW THE BLADE KEPT OSCILLATING WHILE IT WAS HANGING ON THE FIELD. NO ONE KNEW IT KEPT OSCILLATING UNTIL IT BURNED THROUGH A RESIDENT'S GOWN". THERE WAS NO HARM TO THE RESIDENT. AFTER, "THE SURGEON WANTED TO START USING THE BLADE AND IT COMPLETELY STOPPED OSCILLATING, JUST SPITTING WATER". THE REPRESENTATIVE PRESENT FOR THE CASE TRIED TO TIGHTEN THE BLADE BUT COULD NOT GET IT TO WORK. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. A DELAY IN TREATMENT OF TWO MINUTES WAS REPORTED. THE SUBJECT DISPOSABLE HORN AND BLADE WERE RETURNED TO MISONIX FOR EVALUATION. INSPECTION AND TESTING CONCLUDED THE HORN AND BLADE WERE MISTING PROPERLY. THE CURRENT FREQUENCY OF OCCURRENCE IS WITHIN THE FREQUENCY ORIGINALLY ESTIMATED IN THE ORIGINAL RISK MANAGEMENT REPORT. THEREFORE, THERE IS NO CHANGE TO THE RESIDUAL RISK OR RISK-BENEFIT RATIO. DUE TO THE NATURE IN WHICH ULTRASONIC DEVICES TRANSFER ENERGY INTO THE TARGET TISSUE, THERMAL EVENTS MAY OCCUR. THE INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION K) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS REGARDING THE SURGICAL TECHNIQUE AND DEVICE SETTINGS REQUIRED TO PREVENT THERMAL INJURY TO THE PATIENT OR USER: WARNING THE NEXUS® ULTRASONIC SURGICAL ASPIRATOR SYSTEM IS INTENDED TO BE USED IN VARIOUS TYPES OF INVASIVE, SURGICAL PROCEDURES. THERE MAY BE INDIRECT DANGER TO THE PATIENT SHOULD THE DEVICE FAIL DURING THE PROCEDURE. IT IS RECOMMENDED THAT THE FACILITY FOLLOWS ITS BACK-UP EQUIPMENT PROTOCOLS. CAUTION THE SYSTEM CHECK SHOULD ALWAYS BE DONE IN ADVANCE OF PREPARING PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. CAUTION IT IS STRONGLY ADVISED THAT A STERILE BACKUP HANDPIECE BE READILY AVAILABLE IN THE OPERATING ROOM AS INSURANCE ANY CONTAMINATION OR MALFUNCTION OF THE HANDPIECE USED DURING SURGERY. POTENTIAL BURN HAZARD. WARNING: NEXUS® PROBES HAVE A SILICONE OR HARD PLASTIC SHEATH. COMPRESSING OR BENDING THE SHEATH MAY CAUSE THE SHEATH TO CONTACT THE VIBRATING SURFACE ALONG THE LENGTH OF THE PROBE OR AT THE PROBE TIP AND MAY CAUSE EXCESSIVE HEATING, WHICH MAY BURN USER OR PATIENT TISSUE AT THE SURGICAL SITE. WARNING: EXCESSIVE LOADING OF NEXUS® PROBES AT THE SURGICAL SITE MAY INDUCE HEATING DUE TO VIBRATION AND FRICTION AS TARGET TISSUE IS FRAGMENTED AND EMULSIFIED. IT IS CRITICAL TO MANAGE THE TEMPERATURE OF THE PROBE BY ADJUSTING THE IRRIGATION, ASPIRATION, AND ULTRASOUND SETTINGS, AND SURGICAL TECHNIQUE. TISSUE NECROSIS MAY RESULT IF PROBE TIP IS NOT MOVED RELATIVE TO TISSUE. A CONTINUOUS, LATERAL SWEEPING MOTION IS RECOMMENDED IN ORDER TO MINIMIZE CONTACT DURATION WITH THE ULTRASONIC PROBE TIP AND MINIMIZE HEAT BUILD-UP. WHEN LATERAL MOTION IS NOT POSSIBLE WITHDRAW AND RE-INSERT PROBE TIP FREQUENTLY. WARNING: CONTACT TO VIBRATING ELEMENTS LIKE AN EXTENSION AND ULTRASONIC PROBE TIP MAY CAUSE BURNS AND SHOULD BE AVOIDED BY ALL MEANS. THE HANDPIECE SHOULD ONLY BE HELD AT THE BLACK HANDPIECE HOUSING AREA AND/OR THE BLACK HARD SHEATH. WARNING: A PROTECTIVE SILICONE SLEEVE, INCLUDED WITH CERTAIN PROBE TIPS, REDUCES THE RISK OF THERMAL DAMAGE BUT DOES NOT ELIMINATE IT. CONTACT WITH THE SILICONE SLEEVE SHOULD BE AVOIDED OR KEPT BRIEF WITH MINIMAL AMOUNT OF CONTACT PRESSURE. PRESSURE AND EXTENDED EXPOSURE CAN STILL RESULT IN EXCESSIVE FRICTIONAL HEAT AND CAUSE BURNS. WARNING: CONTACT OF THE RIGID OR SILICONE SHEATHS WITH PATIENT TISSUE UNDER PRESSURE, MAY CREATE A BURN HAZARD. AVOID CONTACT OF SHEATH ELEMENTS WITH PATIENT TISSUE UNDER PRESSURE. WARNING: PROBE TIP TEMPERATURES MAY EXCEED THE TISSUE NECROSIS POINT IF INSUFFICIENT IRRIGANT IS PRESENT AT THE PROBE TIP-TISSUE INTERFACE. FOR HARD TISSUE REMOVAL, ALWAYS USE THE MAXIMUM IRRIGATION FLOWRATE THAT DOES NOT AFFECT THE SURGICAL FIELD OF VIEW, OR IMPACT SURGICAL TECHNIQUE. ADDITIONAL EXTERNAL IRRIGATION, E.G., BY ADMINISTERING STERILE SALINE WITH A SYRINGE OVER THE DISTAL PROBE TIP PORTION, MAY BE NECESSARY FOR REMOVAL OF VERY DENSE, HARD OSSEOUS STRUCTURES. WARNING: HARD TISSUE APPLICATIONS, A MINIMUM IRRIGATION SETTING OF 20 IS RECOMMENDED TO MINIMIZE OR PREVENT THERMAL INJURY AND/OR TISSUE NECROSIS. CAUTION: INSUFFICIENT IRRIGATION AND HIGH TIP PRESSURE (LOADING) UNDER EXTENDED EXPOSURE, E.G., IN TIGHT CAVITIES, ARE TO BE AVOIDED WHILE REMOVING HARD TISSUE. IT IS RECOMMENDED TO WITHDRAW AND RE-INSERT THE ULTRASONIC TIPS (E.G., BLADES & SHAVERS) REPEATEDLY TO RE-ESTABLISH ADEQUATE COOLING AND LUBRICATION. CAUTION: ADDITIONAL EXTERNAL IRRIGATION, E.G., BY ADMINISTERING STERILE SALINE WITH A SYRINGE OVER THE DISTAL TIP PORTION, MAY BE NECESSARY WHEN REMOVING VERY DENSE, HARD OSSEOUS STRUCTURES. CAUTION: PRIME THE IRRIGATION TUBING PRIOR TO USE. AT ALL TIMES ENSURE THAT THE IRRIGATION FLOWS TOWARDS THE HANDPIECE WHEN FOOTSWITCH IS DEPRESSED. IF NO IRRIGATION IS FLOWING, CEASE USE UNTIL FLOW IS RESTORED. THE INVESTIGATION HAS BEEN CONCLUDED.

    Description of Event or Problem · 0

    ON NOVEMBER 11, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER: 110-31-1120, LOT NUMBER: 243238) THAT OCCURRED ON NOVEMBER 08, 2024, DURING A BILATERAL TMJ REPLACEMENT (OMFS). SPECIFICALLY, IT WAS REPORTED THAT "THE SURGEON ACCIDENTALLY STEPPED ON THE FOOTPEDAL AND SOMEHOW THE BLADE KEPT OSCILLATING WHILE IT WAS HANGING ON THE FIELD. NO ONE KNEW IT KEPT OSCILLATING UNTIL IT BURNED THROUGH A RESIDENT'S GOWN". THERE WAS NO HARM TO THE RESIDENT. AFTER, "THE SURGEON WANTED TO START USING THE BLADE AND IT COMPLETELY STOPPED OSCILLATING, JUST SPITTING WATER". THE REPRESENTATIVE PRESENT FOR THE CASE TRIED TO TIGHTEN THE BLADE BUT COULD NOT GET IT TO WORK. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. A DELAY IN TREATMENT OF TWO MINUTES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150942 NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT 20MM, BLUNT BLADE + IRRIGATION TUBING KIT LFL MISONIX, INC. 110-31-1120 243238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other