BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE
Report
- Report Number
- 2435119-2025-00015
- Event Type
- Malfunction
- Date Received
- February 20, 2025
- Date of Event
- January 20, 2025
- Report Date
- February 20, 2025
- Manufacturer
- MISONIX, INC.
- Product Code
- LFL
- PMA / PMN Number
- K070313
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- 003
Narratives
BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE (PART NUMBER MXB-B1, LOT NUMBER 233207). ON (B)(6) 2025, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A BLANKET REPORT INVOLVING EIGHT BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLES (PART NUMBER MXB-B1, LOT NUMBER 233207) THAT OCCURRED DURING EIGHT DIFFERENT SURGICAL PROCEDURES ON DIFFERENT DAYS UTILIZED BY SEPARATE FACILITIES AND SURGEONS. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. A DELAY IN TREATMENT BETWEEN 10 AND 15 MINUTES WAS REPORTED DURING EACH PROCEDURE. SPECIFICALLY, THE REPORTER INDICATED THAT "THE MXB-B1 (LOT: 233207) ARE DAMAGED AT THE SAME SITE DURING USING, SO FAR, THERE ARE 8 EA THIS LOT NUMBER OF MXB-B1 HAVE THIS PROBLEM. ALL OF THESE MXB-B1 DAMAGED IN THE BOTTOM OF SERRATION." MXB-B1 (LOT NUMBER 233207) DATE OF EVENT PROCEDURE 1 11/27/2024 L-SPINE LAMINOTOMY 2 12/3/2024 LEFORT I OSTEOTOMY 3 12/24/2024 L-SPINE LAMINOTOMY 4 12/28/2024 C-SPINE LAMINOPLASTY 5 1/6/2025 C-SPINE LAMINOPLASTY 6 1/20/2025 L-SPINE LAMINOTOMY 7 CONTAMINATED BLADE NOT AVAILABLE FOR EVALUATION 1/20/2025 L-SPINE LAMINOTOMY 8 CONTAMINATED BLADE NOT AVAILABLE FOR EVALUATION 1/22/2025 L-SPINE LAMINOTOMY. THE REPORTER INDICATED THAT TWO OF THE EIGHT SUBJECT DISPOSABLE PROBE TIPS USED DURING THESE EVENTS WERE CONTAMINATED AND WILL NOT BE RETURNED FOR EVALUATION DUE TO RISK. PHOTOS WERE PROVIDED WHICH CONFIRMED THE FRACTURE LOCATION AS INDICATED BY THE REPORTER. THE BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE (PART NUMBER MXB-B1) IS A STERILE KIT CONTAINING MULTIPLE COMPONENT PARTS. FIVE 20MM SHORT EXTENSION HORNS (PART NUMBER E4002ABC06) AND SIX 20MM SERRATED BLADES (PART NUMBER E4007ABC20) WERE RETURNED FOR EVALUATION FROM THE FINISHED GOODS PACKAGED DISPOSABLE KITS USED AT THE TIME OF THE EVENT. THE RETURNED ITEMS WERE NOT MARKED TO INDIVIDUALLY IDENTIFY THE DATE OF THE EVENT OR PROCEDURE IN WHICH EACH ITEM WAS USED. THE EVALUATION CONFIRMED ALL BLADES FRACTURED AT THE SAME LOCATION. THE FRACTURES EXTEND FROM THE MOST PROXIMAL TOOTH OF THE SERRATED SIDE OF THE BLADE MEDIALLY TOWARD THE BLADE SLOT NEAR ITS PROXIMAL END. ADDITIONALLY, THE TIPS OF EACH OF THE BLADES SEEM TO EXHIBIT DARK DISCOLORATION CONSISTENT WITH CHARRING, RANGING FROM MODERATE TO SEVERE. THIS WOULD INDICATE HEAVY LOADING OF THE TIP INTO HARD TISSUE. POTENTIAL ROOT CAUSE OF FAILURE COULD BE DUE TO SIDE-LOADING OF THE BLADE WHILE ADVANCING THROUGH THE BONE. IF THE SIDE IN CONTACT WITH THE BONE IS THE SERRATED EDGE, THIS PLACES THAT SERRATED SIDE OF THE BLADE IN TENSION. THE HIGHEST STRESS LOCATION WOULD BE THE PROXIMAL END OF THE BLADE, WHERE THE FRACTURES ARE OBSERVED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE (PART NUMBER MXB-B1, LOT NUMBER 233207) IN USE AT THE TIME OF THE EVENT. 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. A REVIEW OF POST MARKET SURVEILLANCE DATA FOR THE BONESCALPEL® 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 (BCM-UM, REVISION X) (IFU) FOR THE BONESCALPEL® SYSTEM CONTAINS THE FOLLOWING WARNINGS, CAUTIONS, AND NOTES TO PREVENT BLADE BREAKAGE. WARNING THE BONESCALPEL® 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 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. CAUTION ULTRASONIC ENERGY IS INHIBITED IF EXCESSIVE PHYSICAL FORCE IS APPLIED TO THE ULTRASONIC TIP; USE ONLY ENOUGH FORCE TO GUIDE THE TIP TO THE SURGICAL SITE AND TO ADVANCE IT THROUGH THE TISSUE. DO NOT FORCE THE TIP; ALLOW THE ULTRASONIC ACTION TO DO THE WORK. 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. NOTE LOOSE 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. NOTE CONTACT OF THE ULTRASONIC 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 INVESTIGATION HAS BEEN CONCLUDED.
BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE (PART NUMBER MXB-B1, LOT NUMBER 233207). ON (B)(6) 2025, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A BLANKET REPORT INVOLVING EIGHT BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLES (PART NUMBER MXB-B1, LOT NUMBER 233207) THAT OCCURRED DURING EIGHT DIFFERENT SURGICAL PROCEDURES ON DIFFERENT DAYS UTILIZED BY SEPARATE FACILITIES AND SURGEONS. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. A DELAY IN TREATMENT BETWEEN 10 AND 15 MINUTES WAS REPORTED DURING EACH PROCEDURE. SPECIFICALLY, THE REPORTER INDICATED THAT "THE MXB-B1 (LOT: 233207) ARE DAMAGED AT THE SAME SITE DURING USING, SO FAR, THERE ARE 8 EA THIS LOT NUMBER OF MXB-B1 HAVE THIS PROBLEM. ALL OF THESE MXB-B1 DAMAGED IN THE BOTTOM OF SERRATION." MXB-B1 (LOT NUMBER 233207) DATE OF EVENT PROCEDURE 1 11/27/2024 L-SPINE LAMINOTOMY 2 12/3/2024 LEFORT I OSTEOTOMY 3 12/24/2024 L-SPINE LAMINOTOMY 4 12/28/2024 C-SPINE LAMINOPLASTY 5 1/6/2025 C-SPINE LAMINOPLASTY 6 1/20/2025 L-SPINE LAMINOTOMY 7 CONTAMINATED BLADE NOT AVAILABLE FOR EVALUATION 1/20/2025 L-SPINE LAMINOTOMY 8 CONTAMINATED BLADE NOT AVAILABLE FOR EVALUATION 1/22/2025 L-SPINE LAMINOTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1634196 | BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE | 20MM, UNILATERAL SERRATIONS DISPOSABLE | LFL | MISONIX, INC. | MXB-B1 | 233207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |