BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21005653 · Received December 23, 2024

    Report

    Report Number
    2435119-2024-00061
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 23, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K231117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NARRATIVE: 2 OF 2. ON (B)(6) 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KITS (PART NUMBER 110-31-1120, LOT NUMBER 243276) THAT OCCURRED DURING AN UNKNOWN PROCEDURE ON THAT SAME DAY. THE REPORTER WAS NOT ABLE TO IDENTIFY SPECIFIC DETAILS OF THE EVENT. HOWEVER, IT WAS CONFIRMED THAT A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED AND MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED OR REQUIRED. SPECIFICALLY, IT WAS REPORTED THAT THE "BLADES SNAPPED AFTER BEING USED FOR 2 MINS". ALL BROKEN PIECES OF BLADES WERE ACCOUNTED FOR. A DELAY IN TREATMENT MAY OR MAY NOT HAVE OCCURRED WHILE THE DISPOSABLE BLADES WERE REPLACED TO CONTINUE THE PROCEDURE. THE REPORTER WAS NOT ABLE TO IDENTIFY SPECIFIC DETAILS OF THE EVENT. HOWEVER, IT WAS CONFIRMED THAT A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED AND MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED OR REQUIRED. SPECIFICALLY, IT WAS REPORTED THAT THE "BLADES BROKE OFF". THE REPORTER INDICATED THE BLADES WERE EITHER CHARRED OR THE BLADES SNAPPED WHILE CUTTING BONE. ALL BROKEN PIECES OF BLADES WERE ACCOUNTED FOR. A DELAY IN TREATMENT OF LESS THAN 15 MINUTES WAS REPORTED WHILE THE DISPOSABLE BLADE WAS REPLACED WITH A NEW ONE FROM INVENTORY AND INSTALLED ONTO THE HANDPIECE. THE REPORTER COULD NOT SPECIFY IN WHICH CASE THE DELAY OCCURRED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING (PART NUMBER 110-31-1120, LOT NUMBER 243276) IN USE AT THE TIME OF THE EVENT. THE LOT WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THERE WERE NO DEVIATIONS FOUND DURING IN-PROCESS OR FINAL INSPECTION OF THE DEVICE. INSPECTION AND TEST RESULTS MET MISONIX SPECIFICATIONS PRIOR TO RELEASE TO COMMERCE. THE SUBJECT DISPOSABLE USED AT THE TIME OF THE EVENT WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF POST MARKET SURVEILLANCE DATA FOR THE NEXUS® SYSTEM DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS FOR 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 K) 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. 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 INVESTIGATION HAS BEEN CONCLUDED.

    Description of Event or Problem · 0

    NARRATIVE: 2 OF 2. ON (B)(6) 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KITS (PART NUMBER 110-31-1120, LOT NUMBER 243276) THAT OCCURRED DURING AN UNKNOWN PROCEDURE ON THAT SAME DAY. THE REPORTER WAS NOT ABLE TO IDENTIFY SPECIFIC DETAILS OF THE EVENT. HOWEVER, IT WAS CONFIRMED THAT A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED AND MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED OR REQUIRED. SPECIFICALLY, IT WAS REPORTED THAT THE "BLADES SNAPPED AFTER BEING USED FOR 2 MINS". ALL BROKEN PIECES OF BLADES WERE ACCOUNTED FOR. A DELAY IN TREATMENT MAY OR MAY NOT HAVE OCCURRED WHILE THE DISPOSABLE BLADES WERE REPLACED TO CONTINUE THE PROCEDURE. THE REPORTER WAS NOT ABLE TO IDENTIFY SPECIFIC DETAILS OF THE EVENT. HOWEVER, IT WAS CONFIRMED THAT A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED AND MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED OR REQUIRED. SPECIFICALLY, IT WAS REPORTED THAT THE "BLADES BROKE OFF". THE REPORTER INDICATED THE BLADES WERE EITHER CHARRED OR THE BLADES SNAPPED WHILE CUTTING BONE. ALL BROKEN PIECES OF BLADES WERE ACCOUNTED FOR. A DELAY IN TREATMENT OF LESS THAN 15 MINUTES WAS REPORTED WHILE THE DISPOSABLE BLADE WAS REPLACED WITH A NEW ONE FROM INVENTORY AND INSTALLED ONTO THE HANDPIECE. THE REPORTER COULD NOT SPECIFY IN WHICH CASE THE DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617079 NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT 20MM, BLUNT BLADE + IRRIGATION TUBING KIT LFL MISONIX, INC. 110-31-1120 243276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other