NEXUS® BONESCALPEL® 10MM, BLUNT BLADE + IRRIGATION TUBING KIT
Report
- Report Number
- 2435119-2025-00040
- Event Type
- Injury
- Date Received
- December 3, 2025
- Date of Event
- November 3, 2025
- Report Date
- December 3, 2025
- Manufacturer
- MISONIX, INC.
- Product Code
- LFL
- PMA / PMN Number
- K231117
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- 003
Narratives
ON NOVEMBER 03, 2025, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A NEXUS® BONESCALPEL® 10MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER 110-31-1110, LOT NUMBER 253073). SPECIFICALLY, THE REPORTER INDICATED THAT THE PATIENT EXPERIENCED THERMAL INJURY TO THE LIP DURING A LEFORT (RECONSTRUCTION MIDFACE) PROCEDURE. THE DEGREE OF THE BURN WAS NOT SPECIFIED. MEDICAL INTERVENTION WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. THE REPORTER INDICATED THE SUBJECT DISPOSABLE PROBE TIP USED AT THE TIME OF THE EVENT 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 THERMAL INJURY TO THE PATIENT OR USER. THE CURRENT FREQUENCY IS BELOW THE LIKELIHOOD OF OCCURRENCE IN THE RISK MANAGEMENT REPORT. THERE IS NO CHANGE IN RESIDUAL RISK OR RISK-BENEFIT. DUE TO THE NATURE IN WHICH ULTRASONIC DEVICES TRANSFER ENERGY INTO THE TARGET TISSUE, THERMAL EVENTS MAY OCCUR. THE INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION L) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS REGARDING THE SURGICAL TECHNIQUE AND DEVICE SETTINGS REQUIRED TO PREVENT THERMAL INJURY TO THE PATIENT OR USER: 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. CAUTION IT IS STRONGLY ADVISED THAT A STERILE BACKUP HANDPIECE BE READILY AVAILABLE IN THE OPERATING ROOM AS INSURANCE ANY CONTAMINATION OR MALFUNCTION OF THE HANDPIECE USED DURING SURGERY. 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: A PROTECTIVE SILICONE SLEEVE, INCLUDED WITH CERTAIN PROBE TIPS, REDUCES THE RISK OF THERMAL DAMAGE BUT DOES NOT ELIMINATE IT. CONTACT WITH THE SILICONE SLEEVE SHOULD BE AVOIDED OR KEPT BRIEF WITH MINIMAL AMOUNT OF CONTACT PRESSURE. PRESSURE AND EXTENDED EXPOSURE CAN STILL RESULT IN EXCESSIVE FRICTIONAL HEAT AND CAUSE BURNS. WARNING: CONTACT OF THE RIGID OR SILICONE SHEATHS WITH PATIENT TISSUE UNDER PRESSURE, MAY CREATE A BURN HAZARD. AVOID CONTACT OF SHEATH ELEMENTS WITH PATIENT TISSUE UNDER PRESSURE. 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 REPORTER INDICATED THE SUBJECT DISPOSABLE PROBE TIP USED AT THE TIME OF THE EVENT WILL NOT BE RETURNED FOR EVALUATION. THIS INVESTIGATION WILL BE RE-OPENED IF ADDITIONAL DETAILS OF THE EVENT ARE RECEIVED AT A LATER DATE.
ON NOVEMBER 03, 2025, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A NEXUS® BONESCALPEL® 10MM, BLUNT BLADE + IRRIGATION TUBING KIT (PART NUMBER 110-31-1110, LOT NUMBER 253073). SPECIFICALLY, THE REPORTER INDICATED THAT THE PATIENT EXPERIENCED THERMAL INJURY TO THE LIP DURING A LEFORT (RECONSTRUCTION MIDFACE) PROCEDURE. THE DEGREE OF THE BURN WAS NOT SPECIFIED. MEDICAL INTERVENTION WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2862857 | NEXUS® BONESCALPEL® 10MM, BLUNT BLADE + IRRIGATION TUBING KIT | 10MM, BLUNT BLADE + IRRIGATION TUBING KIT | LFL | MISONIX, INC. | 110-31-1110 | 253073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |