BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS® BONESCALPEL® 10MM BLUNT BLADE AND IRRIGATION TUBING

    MDR report key: 15032939 · Received July 15, 2022

    Report

    Report Number
    2435119-2022-00006
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    March 29, 2022
    Report Date
    July 15, 2022
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K190160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON JUNE 17, 2022, MISONIX RECEIVED MEDWATCH USER REPORT (B)(4). THE REPORT DOES NOT MATCH ANY COMPLAINTS RECEIVED IN THE TIMEFRAME OF THE EVENT. THE REPORTED EVENT TOOK PLACE ON (B)(6) 2022, WHILE USING THE NEXUS® BONESCALPEL® 10MM BLUNT BLADE AND IRRIGATION TUBING (PART NUMBER 110-31-1110). 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 REPORTED. IT WAS REPORTED THAT "DURING A SPINE PROCEDURE, WE WERE USING THE MISONIX BONE SCALPEL (REF#110-31-110, LOT #203166) WHEN THE TIP OF THE BLADE ON THE SCALPEL BROKE OFF. THE TEAM WAS NOTIFIED IMMEDIATELY, AND THE TIP WAS SEARCHED FOR ON THE FIELD AND WITHIN THE WOUND. THE TIP WAS NOT RECOVERED FROM THE WOUND AND NOT FOUND ON THE FIELD. THE MD DECIDED TO CONTINUE WITH THE PROCEDURE. X-RAY WAS NOTIFIED UPON CLOSING AND A FLAT PLATE WAS ORDERED FOR THE PATIENT. THE RADIOLOGIST READ THE X-RAY AND THE PIECE WAS NOT DETECTED IN THE WOUND. THE MD CONTINUED TO CLOSE, AND THE CHART WAS CHARTED APPROPRIATELY UPON THIS RESULT." THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE NEXUS® BONESCALPEL® 10MM BLUNT BLADE AND IRRIGATION TUBING (PART NUMBER 110-31-1110). LOT #203166 WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. INSPECTION AND TEST RESULTS MET SPECIFICATIONS. THERE WERE NO DEVIATIONS OR EXCEPTIONS NOTED. A REVIEW OF ALL AVAILABLE POST-MARKET SURVEILLANCE INFORMATION INVOLVING THIS PRODUCT AND LOT NUMBER FOR BLADE BREAKAGES DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS. 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 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 NEXUS® IFU (100-10-1000, REVISION F) CONTAINS 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 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. THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED TO MISONIX FOR EVALUATION, THEREFORE A THOROUGH INVESTIGATION COULD NOT BE CONDUCTED. MISONIX IS ACTIVELY WORKING WITH THE CUSTOMER TO GATHER ADDITIONAL DETAILS TO COMPLETE THE INVESTIGATION. UPON RETURN A FULL ENGINEERING EVALUATION WILL BE COMPLETED TO ESTABLISH POSSIBLE ROOT CAUSE OF THE NON-CONFORMANCE.

    Description of Event or Problem · 0

    ON JUNE 17, 2022, MISONIX RECEIVED MEDWATCH USER REPORT (B)(4). THE REPORT DOES NOT MATCH ANY COMPLAINTS RECEIVED IN THE TIMEFRAME OF THE EVENT. THE REPORTED EVENT TOOK PLACE ON (B)(6) 2022, WHILE USING THE NEXUS® BONESCALPEL® 10MM BLUNT BLADE AND IRRIGATION TUBING (PART NUMBER 110-31-1110). 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 REPORTED. IT WAS REPORTED THAT "DURING A SPINE PROCEDURE, WE WERE USING THE MISONIX BONE SCALPEL (REF#110-31-110, LOT #203166) WHEN THE TIP OF THE BLADE ON THE SCALPEL BROKE OFF. THE TEAM WAS NOTIFIED IMMEDIATELY, AND THE TIP WAS SEARCHED FOR ON THE FIELD AND WITHIN THE WOUND. THE TIP WAS NOT RECOVERED FROM THE WOUND AND NOT FOUND ON THE FIELD. THE MD DECIDED TO CONTINUE WITH THE PROCEDURE. X-RAY WAS NOTIFIED UPON CLOSING AND A FLAT PLATE WAS ORDERED FOR THE PATIENT. THE RADIOLOGIST READ THE X-RAY AND THE PIECE WAS NOT DETECTED IN THE WOUND. THE MD CONTINUED TO CLOSE, AND THE CHART WAS CHARTED APPROPRIATELY UPON THIS RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136719 NEXUS® BONESCALPEL® 10MM BLUNT BLADE AND IRRIGATION TUBING ULTRASONIC SURGICAL SYSTEM DISPOSABLE LFL MISONIX, INC. 110-31-1110 203166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other