NEXUS® BONESCALPEL® 20MM, UNI-LATERAL SERRATED BLADE + IRRIGATION TUBING KIT
Report
- Report Number
- 2435119-2024-00031
- Event Type
- Malfunction
- Date Received
- November 6, 2024
- Date of Event
- October 3, 2024
- Report Date
- February 11, 2025
- Manufacturer
- MISONIX, INC.
- Product Code
- LFL
- PMA / PMN Number
- K231117
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
FOLLOW UP # 1: THE NEXUS® BONESCALPEL® 20MM, UNI-LATERAL SERRATED BLADE + IRRIGATION TUBING KITS (PART NUMBER 110-31-1121) IS A STERILE KIT CONTAINING MULTIPLE COMPONENT PARTS. BOTH BLADES EXHIBITED CHARRING AND DEFORMATION OF THE DISTAL TIP INDICATING HEAVY LOADING AND HIGH TEMPERATURES. BOTH BLADES ALSO EXHIBIT A FAILURE ON ONE LATERAL EDGE WITH SERRATIONS, AT THE MOST PROXIMAL TOOTH ROOT. THE FAILURE DID NOT PROPAGATE THROUGH BOTH LATERAL LEGS, WITH THE NON-SERRATED SIDE REMAINING INTACT. THE COMBINATION OF DISCOLORATION AND THE NOTED FAILURE LOCATION WOULD INDICATE APPLICATION OF HIGH LATERAL (IN-PLANE) TIP LOADING ASSOCIATED WITH AN AGGRESSIVE TECHNIQUE. LOADING OF THIS NATURE PLACES THE PROXIMAL SERRATED TOOTH ROOT IN TENSION. THIS TENSION, IN COMBINATION WITH CYCLIC ULTRASONIC STRESSES INCLUDING TENSILE PORTION OF CYCLE LOAD, MAY HAVE CONTRIBUTED TO A FATIGUE FAILURE OF THE BLADE. THE INVESTIGATION HAS BEEN CONCLUDED.
ON OCTOBER 08, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO NEXUS® BONESCALPEL® 20MM, UNI-LATERAL SERRATED BLADE + IRRIGATION TUBING KITS (PART NUMBER 110-31-1121, LOT NUMBER 243034) THAT OCCURRED ON (B)(6) 2024, DURING A T10-PELVIS POSTERIOR SPINAL FUSION. SPECIFICALLY, IT WAS REPORTED THAT TWO DISPOSABLES BROKE DURING THE CASE. THE REPORTER INDICATED, UNDER MICROSCOPIC OBSERVATION, THAT THERE WAS A CRACK TO THE PROBE OF EACH DISPOSABLE USED, DIRECTLY ON THE STEM BELOW WHERE THE BLADE TIP SCREWS INTO THE PROBE. 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. THE SUBJECT DISPOSABLES USED AT THE TIME OF THE EVENT WERE DISCARDED BY THE FACILITY. 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.
ON (B)(6) 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO NEXUS® BONESCALPEL® 20MM, UNI-LATERAL SERRATED BLADE + IRRIGATION TUBING KITS (PART NUMBER 110-31-1121, LOT NUMBER 243034) THAT OCCURRED ON (B)(6) 2024, DURING A T10-PELVIS POSTERIOR SPINAL FUSION. SPECIFICALLY, IT WAS REPORTED THAT TWO DISPOSABLES BROKE DURING THE CASE. THE REPORTER INDICATED, UNDER MICROSCOPIC OBSERVATION, THAT THERE WAS A CRACK TO THE PROBE OF EACH DISPOSABLE USED, DIRECTLY ON THE STEM BELOW WHERE THE BLADE TIP SCREWS INTO THE PROBE. 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.
ON OCTOBER 08, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO NEXUS® BONESCALPEL® 20MM, UNI-LATERAL SERRATED BLADE + IRRIGATION TUBING KITS (PART NUMBER 110-31-1121, LOT NUMBER 243034) THAT OCCURRED ON (B)(6) 2024, DURING A T10-PELVIS POSTERIOR SPINAL FUSION. SPECIFICALLY, IT WAS REPORTED THAT TWO DISPOSABLES BROKE DURING THE CASE. THE REPORTER INDICATED, UNDER MICROSCOPIC OBSERVATION, THAT THERE WAS A CRACK TO THE PROBE OF EACH DISPOSABLE USED, DIRECTLY ON THE STEM BELOW WHERE THE BLADE TIP SCREWS INTO THE PROBE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1860773 | NEXUS® BONESCALPEL® 20MM, UNI-LATERAL SERRATED BLADE + IRRIGATION TUBING KIT | 20MM, UNI-LATERAL SERRATED BLADE + IRRIGATION TUBING KIT | LFL | MISONIX, INC. | 110-31-1121 | 243034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |