NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
Report
- Report Number
- 2435119-2024-00063
- Event Type
- Injury
- Date Received
- January 6, 2025
- Date of Event
- December 6, 2024
- Report Date
- January 5, 2025
- Manufacturer
- MISONIX, INC.
- Product Code
- LFL
- PMA / PMN Number
- K231117
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER 110-31-1120, LOT NUMBER 243248) ON DECEMBER 06, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO DISPOSABLE PRODUCTS DURING A LAMINECTOMY PROCEDURE ON THAT SAME DAY. A NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER 110-31-1120, LOT NUMBER 243248) AND A BONESCALPEL® 20MM, BLUNT DISPOSABLE (PART NUMBER MXB-20, LOT NUMBER 233331) WERE THE SUBJECT PRODUCTS INVOLVED IN THE EVENT. SPECIFICALLY, IT WAS REPORTED THAT "THE NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER 110-31-1120, LOT NUMBER 243248) WAS WORKING THEN STOPPED AND BEGAN SPITTING SALINE. MECHANICAL LIMIT WARNING APPEARED ON SCREEN. SWITCHED TO NEW BLADE (BONESCALPEL® 20MM, BLUNT DISPOSABLE (PART NUMBER MXB-20, LOT NUMBER 233331) AND UNPLUGGED/PLUGGED IN NEXUS® STANDARD HANDPIECE TO "RESET" AND PROBLEM RESOLVED. DR. SAID WHEN BLADE STOPPED WORKING, HE NOTICED A DURAL TEAR." A DURAL REPAIR WAS NEEDED WHICH ADDED AN ADDITIONAL 30 MINUTES TO PROCEDURAL TIME. NO COMPLICATIONS RESULTED FROM THE DELAY. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE MECHANICAL LIMIT ERROR OCCURRED ONCE THE SALINE STARTED "SPITTING" AND THE SURGEON WAS UNABLE TO GET TO THE SECOND SIDE BEFORE THE BLADE "STARTS LIMITING." IN THIS CASE, THE BLADES "DOESN'T LIMIT, AND THE SOUND IS OFF, AND THE BLADE STOPS." THE DRILL ONLY STOPS WITH THE MECHANICAL LIMIT WARNING IF THE DRILL IS HEATING UP OR IS PLACED IN ONE POSITION AND HELD IN THAT POSITION WITH EITHER A DOWNWARD FORCE TO GET THROUGH BONE WITHOUT WORKING IN A CONSTANT IN AND OUT MOTION AND LATERAL MOTION. IN THIS CIRCUMSTANCE, THE DRILL HEATS UP AND THE IRRIGATION CAN NO LONGER REACH THE WORKING TIP. THE CONSTANT IN AND OUT MOTION AND LATERAL MOTION OF THE WORKING TIP OF THE DRILL FACILITATES CONSTANT COOLING AND VARIES THE RESISTANCE PLACED AGAINST THE WORKING TIP OF THE ULTRASONIC BLADE. THIS ENABLES THE DRILL TO CONTINUE WORKING PROPERLY. ANYTIME THE BLADE HEATS UP AND IS PLACED AGAINST EITHER DURA MATER OR LIGAMENTUM FLAVUM OR OTHER TISSUE IT WILL CHAR THAT TISSUE, AND THE HEAT IS WHAT DAMAGES THAT TISSUE AND MAY RESULT IN A LINEAR TEAR. EXPERIENCE WITH PROPER TECHNIQUE WILL MINIMIZE OR ELIMINATE SUCH EVENTS FROM OCCURRING. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER 110-31-1120, LOT NUMBER 243248) AND THE BONESCALPEL® 20MM, BLUNT DISPOSABLE (PART NUMBER MXB-20, LOT NUMBER 233331) IN USE AT THE TIME OF THE EVENT. THE LOTS WERE MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THERE WERE NO DEVIATIONS FOUND DURING IN-PROCESS OR FINAL INSPECTION OF THE DEVICES. INSPECTION AND TEST RESULTS MET MISONIX SPECIFICATIONS PRIOR TO RELEASE TO COMMERCE. 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) 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 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 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. POTENTIAL BURN HAZARD WARNING NEXUS® PROBES HAVE A SILICONE OR HARD PLASTIC SHEATH. COMPRESSING OR BENDING THE SHEATH MAY CAUSE THE SHEATH TO CONTACT THE VIBRATING SURFACE ALONG THE LENGTH OF THE PROBE OR AT THE PROBE TIP AND MAY CAUSE EXCESSIVE HEATING, WHICH MAY BURN USER OR PATIENT TISSUE AT THE SURGICAL SITE. WARNING EXCESSIVE LOADING OF NEXUS® PROBES AT THE SURGICAL SITE MAY INDUCE HEATING DUE TO VIBRATION AND FRICTION AS TARGET TISSUE IS FRAGMENTED AND EMULSIFIED. IT IS CRITICAL TO MANAGE THE TEMPERATURE OF THE PROBE BY ADJUSTING THE IRRIGATION, ASPIRATION, AND ULTRASOUND SETTINGS, AND SURGICAL TECHNIQUE. TISSUE NECROSIS MAY RESULT IF PROBE TIP IS NOT MOVED RELATIVE TO TISSUE. A CONTINUOUS, LATERAL SWEEPING MOTION IS RECOMMENDED IN ORDER TO MINIMIZE CONTACT DURATION WITH THE ULTRASONIC PROBE TIP AND MINIMIZE HEAT BUILD-UP. WHEN LATERAL MOTION IS NOT POSSIBLE WITHDRAW AND RE-INSERT PROBE TIP FREQUENTLY. WARNING CONTACT TO VIBRATING ELEMENTS LIKE AN EXTENSION AND ULTRASONIC PROBE TIP MAY CAUSE BURNS AND SHOULD BE AVOIDED BY ALL MEANS. THE HANDPIECE SHOULD ONLY BE HELD AT THE BLACK HANDPIECE HOUSING AREA AND/OR THE BLACK HARD SHEATH. WARNING PROBE TIP TEMPERATURES MAY EXCEED THE TISSUE NECROSIS POINT IF INSUFFICIENT IRRIGANT IS PRESENT AT THE PROBE TIP-TISSUE INTERFACE. FOR HARD TISSUE REMOVAL, ALWAYS USE THE MAXIMUM IRRIGATION FLOWRATE THAT DOES NOT AFFECT THE SURGICAL FIELD OF VIEW, OR IMPACT SURGICAL TECHNIQUE. ADDITIONAL EXTERNAL IRRIGATION, E.G., BY ADMINISTERING STERILE SALINE WITH A SYRINGE OVER THE DISTAL PROBE TIP PORTION, MAY BE NECESSARY FOR REMOVAL OF VERY DENSE, HARD OSSEOUS STRUCTURES. WARNING HARD TISSUE APPLICATIONS, A MINIMUM IRRIGATION SETTING OF 20 IS RECOMMENDED TO MINIMIZE OR PREVENT THERMAL INJURY AND/OR TISSUE NECROSIS. CAUTION INSUFFICIENT IRRIGATION AND HIGH TIP PRESSURE (LOADING) UNDER EXTENDED EXPOSURE, E.G., IN TIGHT CAVITIES, ARE TO BE AVOIDED WHILE REMOVING HARD TISSUE. IT IS RECOMMENDED TO WITHDRAW AND RE-INSERT THE ULTRASONIC TIPS (E.G., BLADES & SHAVERS) REPEATEDLY TO RE-ESTABLISH ADEQUATE COOLING AND LUBRICATION. CAUTION ADDITIONAL EXTERNAL IRRIGATION, E.G., BY ADMINISTERING STERILE SALINE WITH A SYRINGE OVER THE DISTAL TIP PORTION, MAY BE NECESSARY WHEN REMOVING VERY DENSE, HARD OSSEOUS STRUCTURES. CAUTION PRIME THE IRRIGATION TUBING PRIOR TO USE. AT ALL TIMES ENSURE THAT THE IRRIGATION FLOWS TOWARDS THE HANDPIECE WHEN FOOTSWITCH IS DEPRESSED. IF NO IRRIGATION IS FLOWING, CEASE USE UNTIL FLOW IS RESTORED. 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 NOTIFICATION IS DISPLAYED TOGETHER WITH AN AUDIBLE INDICATOR AS LONG AS THE FOOTSWITCH IS DEPRESSED. 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. FOLLOW THE CORRECTIVE ACTION BELOW. TABLE 8.2 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. THE SUBJECT DISPOSABLE HAS NOT YET BEEN RETURNED FOR EVALUATION; THEREFORE, A THOROUGH INVESTIGATION COULD NOT BE CONDUCTED AS OF THE TIME OF THIS REPORT. UPON RETURN, A FULL EVALUATION WILL BE COMPLETED TO ESTABLISH POTENTIAL ROOT CAUSE, AND A FOLLOW UP REPORT WILL BE ISSUED.
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER 110-31-1120, LOT NUMBER 243248) ON DECEMBER 06, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO DISPOSABLE PRODUCTS DURING A LAMINECTOMY PROCEDURE ON THAT SAME DAY. A NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER 110-31-1120, LOT NUMBER 243248) AND A BONESCALPEL® 20MM, BLUNT DISPOSABLE (PART NUMBER MXB-20, LOT NUMBER 233331) WERE THE SUBJECT PRODUCTS INVOLVED IN THE EVENT. SPECIFICALLY, IT WAS REPORTED THAT "THE NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER 110-31-1120, LOT NUMBER 243248) WAS WORKING THEN STOPPED AND BEGAN SPITTING SALINE. MECHANICAL LIMIT WARNING APPEARED ON SCREEN. SWITCHED TO NEW BLADE (BONESCALPEL® 20MM, BLUNT DISPOSABLE (PART NUMBER MXB-20, LOT NUMBER 233331) AND UNPLUGGED/PLUGGED IN NEXUS® STANDARD HANDPIECE TO "RESET" AND PROBLEM RESOLVED. DR. SAID WHEN BLADE STOPPED WORKING, HE NOTICED A DURAL TEAR." A DURAL REPAIR WAS NEEDED WHICH ADDED AN ADDITIONAL 30 MINUTES TO PROCEDURAL TIME. NO COMPLICATIONS RESULTED FROM THE DELAY. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE MECHANICAL LIMIT ERROR OCCURRED ONCE THE SALINE STARTED "SPITTING" AND THE SURGEON WAS UNABLE TO GET TO THE SECOND SIDE BEFORE THE BLADE "STARTS LIMITING." IN THIS CASE, THE BLADES "DOESN'T LIMIT, AND THE SOUND IS OFF, AND THE BLADE STOPS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1162055 | NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT | 20MM, BLUNT BLADE + IRRIGATION TUBING KIT | LFL | MISONIX, INC. | 110-31-1120 | 243248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |