BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20403098 · Received October 8, 2024

    Report

    Report Number
    2435119-2024-00013
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 8, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K231117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PART NUMBER: 110-31-1120 (NEXUS® BONESCALPEL®, 20MM, BLUNT BLADE + IRRIGATION TUBING KIT) (QTY. 1) ON SEPTEMBER 06, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT DURING A T11-L5 LAMINECTOMY WITH L3-5 INTERBODY FUSION THAT OCCURRED ON (B)(6) 2024. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON SEPTEMBER 12, 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY. SPECIFICALLY, IT WAS REPORTED THAT WHEN THE SURGEON WAS GETTING PREPARED TO DECOMPRESS, A MECHANICAL LIMIT FAULT MESSAGE APPEARED WHEN THE DISPOSABLE TIP TOUCHED THE BONE. TROUBLESHOOTING WAS PERFORMED AS RECOMMENDED PER THE INSTRUCTIONS FOR USE MANUAL. BACK UP EQUIPMENT PROTOCOLS WERE FOLLOWED WITH OTHER INSTRUMENTS DURING THIS DELAY. IN TOTAL, THE SURGEON USED FIVE (5) MXB-20 (BONESCALPEL®, 20MM, BLUNT BLADE) DISPOSABLES AND ONE (1) 110-31-1120 (NEXUS® BONESCALPEL®, 20MM, BLUNT BLADE + IRRIGATION TUBING KIT). SIX (6) DISPOSABLES WERE RECEIVED BY THE SERVICE DEPARTMENT FOR EVALUATION. THE SERVICE EVALUATION CONFIRMED FIVE (5) OF THE SIX (6) RETURNED HORNS (P/N: E4002ABC06 (20MM SHORT HORN)) WERE CRACKED LEADING TO A MECHANICAL LIMIT FAILURE WHICH CONFIRMED THE CUSTOMER'S STATED COMPLAINT. THE LOT NUMBER OF THE FINISHED GOOD DISPOSABLE, 110-31-1120 (NEXUS® BONESCALPEL®, 20MM, BLUNT BLADE + IRRIGATION TUBING KIT) WAS NOT REPORTED. THEREFORE, THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. A REVIEW OF ALL AVAILABLE POST MARKET SURVEILLANCE DATA HAS NOT SHOWN ADVERSE TRENDS RELATED TO THIS OR SIMILAR EVENTS. THE CURRENT FREQUENCY OF OCCURRENCE IS WITHIN THE FREQUENCY IN THE ORIGINAL RISK MANAGEMENT REPORT. THERE IS NO CHANGE TO THE RESIDUAL RISK OR RISK-BENEFIT RATIO. THE INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION K) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS IN THE EVENT OF A MECHANICAL LIMIT ALERT/NOTIFICATION: 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. IN THE EVENT OF ERROR, SUCH AS A MECHANICAL LIMIT, THE MAIN SCREEN IS REPLACED BY ALERT SCREENS. THE CONSOLE MONITORS THE ULTRASONIC OUTPUT AT ALL TIMES AND ALERTS IN CASES OF OVERLOAD OR MALFUNCTION OF THE VIBRATING ELEMENTS (HANDPIECE, EXTENSION AND ULTRASONIC TIP). A "LIMIT" ALERT IS DISPLAYED TOGETHER WITH A PULSED AUDIBLE INDICATOR AS LONG AS THE FOOTSWITCH IS DEPRESSED. ULTRASOUND AND IRRIGATION ARE DEACTIVATED TEMPORARILY. TABLE 9.2 CONTAINS STEPS FOR THE USER TO TAKE SHOULD A MECHANICAL LIMIT ALERT APPEAR DURING USE AS WELL AS RECOMMENDED CORRECTIVE ACTIONS TO TAKE. THE POSSIBLE CAUSES LISTED FOR A MECHANICAL LIMIT ALERT ARE: 1. TIP OVERLOAD 2. LOOSE OR DAMAGED COMPONENT 3. DEFECTIVE HANDPIECE NUMBERS 1 AND 2 HAVE CORRECTIVE ACTIONS LISTED THAT CAN BE PERFORMED BY THE USER, HOWEVER IF THE LISTED CORRECTIVE ACTIONS ARE FOLLOWED AND THE ALERT CONTINUES, THE HANDPIECE MAY NEED TO BE REPLACED. IN THE EVENT THAT THE HANDPIECE NEEDS TO BE REPLACED, THE FACILITY SHOULD FOLLOW THEIR BACK-UP EQUIPMENT PROTOCOLS AS LISTED IN THE GENERAL SAFETY REQUIREMENTS. TIP OVERLOAD CAN OCCUR DURING HARD TISSUE REMOVAL WHEN APPLYING EXCESSIVE TIP PRESSURE OR FACING STRONG TISSUE RESISTANCE, E.G. FROM THICK CORTICAL BONE. THIS CAN LEAD TO STALLING OF THE ULTRASONIC TIP. A PULSED AUDIBLE SIGNAL ALERTS OF THE STALLING AND THE ULTRASOUND IS DEACTIVATED. RELEASE THE FOOTSWITCH BRIEFLY AND REDUCE THE TIP PRESSURE, E.G. BY RETRIEVING THE ULTRASONIC TIP. DEPRESS THE FOOTSWITCH AGAIN AND CONTINUE WITH REDUCED TIP PRESSURE. CONSIDER USING HIGHER AMPLITUDE SETTING OR REDUCED LOADING IF STALLING PERSISTS. THE INVESTIGATION HAS BEEN CONCLUDED.

    Description of Event or Problem · 0

    PART NUMBER: 110-31-1120 (NEXUS® BONESCALPEL®, 20MM, BLUNT BLADE + IRRIGATION TUBING KIT) (QTY. 1). ON SEPTEMBER 06, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT DURING A T11-L5 LAMINECTOMY WITH L3-5 INTERBODY FUSION THAT OCCURRED ON (B)(6) 2024. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON SEPTEMBER 12, 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY. SPECIFICALLY, IT WAS REPORTED THAT WHEN THE SURGEON WAS GETTING PREPARED TO DECOMPRESS, A MECHANICAL LIMIT FAULT MESSAGE APPEARED WHEN THE DISPOSABLE TIP TOUCHED THE BONE. TROUBLESHOOTING WAS PERFORMED AS RECOMMENDED PER THE INSTRUCTIONS FOR USE MANUAL. BACK UP EQUIPMENT PROTOCOLS WERE FOLLOWED WITH OTHER INSTRUMENTS DURING THIS DELAY. IN TOTAL, THE SURGEON USED FIVE (5) MXB-20 (BONESCALPEL®, 20MM, BLUNT BLADE) DISPOSABLES AND ONE (1) 110-31-1120 (NEXUS® BONESCALPEL®, 20MM, BLUNT BLADE + IRRIGATION TUBING KIT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54307 NEXUS® BONESCALPEL®, 20MM, BLUNT BLADE + IRRIGATION TUBING KIT 20MM, BLUNT BLADE + IRRIGATION TUBING KIT LFL MISONIX, INC. 110-31-1120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other