BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS® BONESCALPEL® MIS 20 MM BLADE AND SHEATH + IRRIGATION TUBING KIT

    MDR report key: 20646440 · Received November 8, 2024

    Report

    Report Number
    2435119-2024-00032
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    October 2, 2024
    Report Date
    November 8, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K231117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A NEXUS® BONESCALPEL® MIS 20 MM BLADE AND SHEATH + IRRIGATION TUBING KIT (PART NUMBER 110-31-2120) THAT OCCURRED ON (B)(6) 2024, DURING A THORACIC DECOMPRESSION AND FUSION. SPECIFICALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF MOTORS IN THE LOWER EXTREMITY OF BOTH LEGS DURING THE PROCEDURE. WHEN THE SURGEON WAS MADE AWARE OF THE MOTOR LOSS, THEY BRIEFLY STOPPED USING THE NEXUS® BONESCALPEL® PRODUCT AND SWITCHED TO A MORE TRADITIONAL METHOD TO CONTINUE THE PROCEDURE AND THE MOTORS IMPROVED. THE NEXUS® BONESCALPEL® PRODUCT WAS UTILIZED A FEW MORE TIMES TO HELP COMPLETE THE CASE. MEDICAL INTERVENTION WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. A MALFUNCTION WAS NOT REPORTED. ADDITIONAL FOLLOW UP RECEIVED FROM THE SURGEON INDICATED THAT THE THAT THE PATIENT IS DOING FINE, AND THE SURGEON DIDN'T BELIEVE THAT THE NEXUS® BONESCALPEL® WAS AN ISSUE DURING THE PROCEDURE. THE LOT NUMBER FOR A NEXUS® BONESCALPEL® MIS 20 MM BLADE AND SHEATH + IRRIGATION TUBING KIT (PART NUMBER 110-31-2120) WAS NOT REPORTED; THEREFORE, A COMPLETE DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THE SUBJECT DISPOSABLE PROBE TIP USED AT THE TIME OF THE EVENT WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. 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. THE INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION K) (IFU) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNING AND CAUTION: 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. THE INVESTIGATION HAS BEEN CONCLUDED. THIS CASE MAY BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A NEXUS® BONESCALPEL® MIS 20 MM BLADE AND SHEATH + IRRIGATION TUBING KIT (PART NUMBER 110-31-2120) THAT OCCURRED ON (B)(6) 2024, DURING A THORACIC DECOMPRESSION AND FUSION. SPECIFICALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF MOTORS IN THE LOWER EXTREMITY OF BOTH LEGS DURING THE PROCEDURE. WHEN THE SURGEON WAS MADE AWARE OF THE MOTOR LOSS, THEY BRIEFLY STOPPED USING THE NEXUS® BONESCALPEL® PRODUCT AND SWITCHED TO A MORE TRADITIONAL METHOD TO CONTINUE THE PROCEDURE AND THE MOTORS IMPROVED. THE NEXUS® BONESCALPEL® PRODUCT WAS UTILIZED A FEW MORE TIMES TO HELP COMPLETE THE CASE. MEDICAL INTERVENTION WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. A MALFUNCTION WAS NOT REPORTED. ADDITIONAL FOLLOW UP RECEIVED FROM THE SURGEON INDICATED THAT THE THAT THE PATIENT IS DOING FINE, AND THE SURGEON DIDN'T BELIEVE THAT THE NEXUS® BONESCALPEL® WAS AN ISSUE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943091 NEXUS® BONESCALPEL® MIS 20 MM BLADE AND SHEATH + IRRIGATION TUBING KIT MIS 20 MM BLADE AND SHEATH + IRRIGATION TUBING KIT LFL MISONIX, INC. 110-31-2120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other