NEXUS® BONESCALPEL® 20MM MIS, BLUNT BLADE, SHEATH & TUBING KIT

Report

Report Number: 2435119-2024-00038
Event Type: Malfunction
Date Received: November 21, 2024
Date of Event: September 16, 2024
Report Date: November 21, 2024
Manufacturer: MISONIX, INC.
Product Code: LFL
PMA / PMN Number: K231117
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ON OCTOBER 22, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO NEXUS® BONESCALPEL® 20MM MIS, BLUNT BLADE, SHEATH & TUBING KITS (PART NUMBER 110-31-2120, LOT NUMBER 243142) DURING A POSTERIOR LUMBAR FUSION THAT OCCURRED ON (B)(6) 2024. SPECIFICALLY, IT WAS REPORTED THAT THE "20MM SERRATED BLADES BROKE NEAR THE TIP DURING TYPICAL CASE USAGE" AND A "MECHANICAL LIMIT ERROR" WAS DISPLAYED. 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 DEVICE HISTORY RECORD WAS REVIEWED FOR THE NEXUS® BONESCALPEL® 20MM MIS, BLUNT BLADE, SHEATH & TUBING KITS (PART NUMBER 110-31-2120, LOT NUMBER 243142) 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 DISPOSABLES 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 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 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 INVESTIGATION HAS BEEN CONCLUDED.

Description of Event or Problem · 0

ON OCTOBER 22, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO NEXUS® BONESCALPEL® 20MM MIS, BLUNT BLADE, SHEATH & TUBING KITS (PART NUMBER 110-31-2120, LOT NUMBER 243142) DURING A POSTERIOR LUMBAR FUSION THAT OCCURRED ON (B)(6) 2024. SPECIFICALLY, IT WAS REPORTED THAT THE "20MM SERRATED BLADES BROKE NEAR THE TIP DURING TYPICAL CASE USAGE" AND A "MECHANICAL LIMIT ERROR" WAS DISPLAYED. 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
1852708	NEXUS® BONESCALPEL® 20MM MIS, BLUNT BLADE, SHEATH & TUBING KIT	20MM MIS, BLUNT BLADE, SHEATH & TUBING KIT	LFL	MISONIX, INC.	110-31-2120	243142

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other