BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS® BONESCALPEL® 25MM BLUNT BLADE AND IRRIGATION TUBING KIT

    MDR report key: 21480110 · Received February 27, 2025

    Report

    Report Number
    2435119-2025-00018
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Report Date
    February 27, 2025
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K231117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 28, 2025, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED MEDSUN REPORT #(B)(4) INVOLVING A NEXUS® BONESCALPEL® 25 MM BLUNT BLADE AND IRRIGATION TUBING KIT (PART NUMBER 110-31-1125, LOT NUMBER 243188). THE REPORT DOES NOT MATCH ANY COMPLAINTS RECEIVED IN THE TIMEFRAME OF THE EVENT. THE SPECIFIC DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, THE REPORT INDICATED THE EVENT TOOK PLACE IN DECEMBER 2024. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. SPECIFICALLY, THE MEDSUN REPORT INDICATED: "THE PROCEDURE DONE TO THE PATIENT WAS POSTERIOR LUMBAR LAMINECTOMY. MISONIX NEXUS BONESCALPEL WAS USED DURING THE PROCEDURE. TWO HOURS INTO THE PROCEDURE, SCRUB TECH NOTICED THAT THE BONE SCALPEL TIP WAS CHARRED AND BENT. I OPENED A NEW NEXUS BONESCALPEL SUPPLY. SPINE COORDINATOR CALLED AND INFORMED ABOUT WHAT HAPPENED." TYPICALLY, CHARRING AND DEFORMATION OF THE TIP IS AN INDICATION OF HEAVY LOADING AND HIGH TEMPERATURES DURING USAGE. THIS TENSION, IN COMBINATION WITH CYCLIC ULTRASONIC STRESSES INCLUDING TENSILE PORTION OF CYCLE LOAD, MAY HAVE CONTRIBUTED TO A FATIGUE FAILURE OF THE BLADE. A REVIEW OF POST MARKET SURVEILLANCE DATA FOR THE NEXUS® SYSTEM DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS FOR DEFORMATION OR BREAKAGE OF ULTRASONIC PROBE TIPS. 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 OF THE DEVICE. THE RISK OF HARM IS MITIGATED BY THE NATURE IN WHICH TITANIUM ULTRASONIC BLADES BREAK DURING USE. TITANIUM DOES NOT SHATTER, SPLINTER, OR CREATE MULTIPLE FRAGMENTS THAT WOULD BE DIFFICULT TO LOCATE OR REMOVE FROM THE SURGICAL FIELD. IN MOST CASES, THE BROKEN PIECES CAN BE EASILY IDENTIFIED BY DIRECT VISUAL EXAMINATION AND REMOVED FROM THE SURGICAL FIELD. IN CASES WHERE BROKEN PIECES CANNOT BE IDENTIFIED VISUALLY, ENHANCED VISUALIZATION THROUGH THE ROUTINE USE OF LOUPE-FITTED EYEGLASSES OR MICROSCOPES CAN AID IN IDENTIFYING AND REMOVING BROKEN PIECES FROM THE SURGICAL FIELD. SURGICAL SUITES TYPICALLY HAVE ACCESS TO DIAGNOSTIC IMAGING EQUIPMENT, SUCH AS X-RAY OR FLUOROSCOPY, AND WOULD BE ABLE TO QUICKLY IDENTIFY AND LOCATE ANY FRAGMENTS NOT FOUND BY DIRECT OR ENHANCED VISUALIZATION. THE BROKEN PIECES THAT REMAIN IN THE OPERATIVE FIELD CAN THEREFORE BE FOUND AND EXTRACTED QUICKLY AND EASILY WITHOUT SIGNIFICANT DELAY IN THE SURGICAL PROCEDURE. THE INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION L) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS TO PREVENT BLADE BREAKAGE. 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. WARNING: ULTRASONIC PROBE TIPS CAN BREAK UNDER EXCESSIVE USE IN EXTREME CONDITIONS, E.G. WHEN CUTTING FOR EXTENDED DURATION IN TIGHT CAVITIES WITH LIMITED LATERAL MOTION. THE PROBE TIP COULD BREAK INTO TWO OR MORE FRAGMENTS WITH THE MAIN FRAGMENT REMAINING ATTACHED TO THE HANDPIECE. ALL FRAGMENTS MUST BE RETRIEVED IMMEDIATELY FROM THE SURGICAL SITE. THE FRAGMENTS SHOULD BE CHECKED TO ENSURE THAT NO FURTHER PIECES ARE MISSING. IT IS POSSIBLE THAT A FRAGMENT IS PROPELLED OUTSIDE OF THE SURGICAL CAVITY. DIAGNOSTIC IMAGING, SUCH AS X-RAY, MUST BE USED IF A FRAGMENT CANNOT BE FOUND TO CONFIRM THAT THE BROKEN PIECE IS OUTSIDE OF THE SURGICAL CAVITY. WARNING: BREAKAGE OF ULTRASONIC PROBE TIPS WILL RESULT IN SHARP EDGES THAT CAN BE HARMFUL TO SOFT TISSUE EVEN WITHOUT ACTIVATION OF ULTRASOUND. PROBE TIPS CAN BEND OR DEFORM BEFORE THEY ACTUALLY BREAK. PROBE TIPS SHOWING SIGNS OF DEFORMATION OR CRACKING SHOULD BE REPLACED IMMEDIATELY SINCE PROBE TIP BREAKAGE IS OTHERWISE IMMINENT. DO NOT BEND OR TWIST THE ULTRASONIC PROBE TIPS SINCE IT REDUCES THE STRUCTURAL INTEGRITY AND CAN RESULT IN PROBE TIP BREAKAGE DURING USE. DISPOSE OF DEFORMED OR BROKEN PROBE TIPS IMMEDIATELY IN A SHARPS CONTAINER IN ACCORDANCE WITH YOUR FACILITY BIOLOGICAL HAZARDOUS WASTE PROCEDURE. WARNING: DURING SYSTEM CHECK, MAKE SURE THE PROBE TIP OF THE HANDPIECE IS FREE FROM CONTACT WITH ANY OBJECT. ALLOWING CONTACT WITH THE PROBE TIP MAY RESULT IN DAMAGE AND/OR PERSONAL INJURY. 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. REFER TO SECTION 7.11 - SYSTEM CHECK. CAUTION: LOOSE PROBE TIP/TISSUE CONTACT UPON AN INITIAL BONE INCISION CAN CAUSE A THIN PROBE TIP TO RESONATE NOT ONLY LONGITUDINALLY BUT ALSO TRANSVERSELY. THIS CAN CAUSE A THIN PROBE TIP TO BREAK. IT IS NECESSARY TO ENGAGE BONE ACTIVELY AND WITH A MINIMAL PROBE TIP PRESSURE GREATER THAN ZERO IN ORDER TO PREVENT THE SHATTERING. CAUTION: CONTACT OF THE ULTRASONIC PROBE TIP OR THE EXPOSED EXTENSION WITH METAL, SURGICAL INSTRUMENTS OR OTHER OBJECTS DURING ULTRASOUND USE MUST BE AVOIDED. SUCH CONTACT CAN DAMAGE THE ULTRASONIC COMPONENTS VERY EASILY AND MAY RESULT IN COMPROMISED PERFORMANCE, INCLUDING FAILURE. DISCARD ANY EXTENSIONS OR PROBE TIPS THAT SHOW SIGNS OF DAMAGES LIKE GOUGES, NICKS OR FRACTURES. EXTERNAL ASPIRATION MAY BE USED BUT IT IS RECOMMENDED THAT A PLASTIC SUCTION PROBE TIP SHOULD BE USED WHEN IN PROXIMITY WITH THE PROBE TIP. CAUTION: THE NEXUS® SYSTEM SHOULD BE FULLY TESTED AND INSPECTED PRIOR TO EACH PROCEDURE. THE CONSOLE, FOOTSWITCH, HANDPIECES, ALL CABLES AND ACCESSORIES SHOULD BE EXAMINED FOR PROPER APPEARANCE AND CONDITION. THE MEDSUN REPORT INDICATED THAT THE DISPOSABLE IS AVAILABLE FOR EVALUATION; HOWEVER, MISONIX HAS NOT YET RECEIVED CORRESPONDENCE REGARDING ITS RETURN FOR EVALUATION. A FULL INVESTIGATION CANNOT BE CARRIED OUT WITHOUT THE DEVICE. THE INVESTIGATION HAS BEEN CONCLUDED AT THIS TIME. THIS CASE MAY BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE.

    Description of Event or Problem · 0

    ON JANUARY 28, 2025, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED MEDSUN REPORT #(B)(4) INVOLVING A NEXUS® BONESCALPEL® 25 MM BLUNT BLADE AND IRRIGATION TUBING KIT (PART NUMBER 110-31-1125, LOT NUMBER 243188). THE REPORT DOES NOT MATCH ANY COMPLAINTS RECEIVED IN THE TIMEFRAME OF THE EVENT. THE SPECIFIC DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, THE REPORT INDICATED THE EVENT TOOK PLACE IN DECEMBER 2024. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. SPECIFICALLY, THE MEDSUN REPORT INDICATED: "THE PROCEDURE DONE TO THE PATIENT WAS POSTERIOR LUMBAR LAMINECTOMY. MISONIX NEXUS BONESCALPEL WAS USED DURING THE PROCEDURE. TWO HOURS INTO THE PROCEDURE, SCRUB TECH NOTICED THAT THE BONE SCALPEL TIP WAS CHARRED AND BENT. I OPENED A NEW NEXUS BONESCALPEL SUPPLY. SPINE COORDINATOR CALLED AND INFORMED ABOUT WHAT HAPPENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810515 NEXUS® BONESCALPEL® 25MM BLUNT BLADE AND IRRIGATION TUBING KIT 25MM BLUNT BLADE AND IRRIGATION TUBING KIT LFL MISONIX, INC. 110-31-1125 243188

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Other