BONESCALPEL® MICROHOOK DISPOSABLE
Report
- Report Number
- 2435119-2024-00012
- Event Type
- Malfunction
- Date Received
- October 4, 2024
- Date of Event
- August 2, 2024
- Report Date
- February 12, 2025
- Manufacturer
- MISONIX, INC.
- Product Code
- LFL
- PMA / PMN Number
- K070313
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON SEPTEMBER 05, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A BONESCALPEL® MICROHOOK DISPOSABLE (PART NUMBER MXB-S1, LOT NUMBER 223305) DURING A LUMBAR FUSION THAT OCCURRED ON (B)(6) 2024. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. SPECIFICALLY, IT WAS REPORTED THAT DURING THE SURGERY THE BLADE BROKE LEAVING A PIECE THAT NEEDED TO BE REMOVED FROM THE WOUND. A NEW BLADE WAS OPENED, AND THE SURGEON EXPERIENCED THE SAME ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED FOR BONESCALPEL® MICROHOOK DISPOSABLE (PART NUMBER MXB-S1, LOT NUMBER 223305) 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 DISPOSABLES HAVE NOT YET BEEN RETURNED FOR EVALUATION. MISONIX IS CURRENTLY IN THE PROCESS OF WORKING WITH THE CUSTOMER FOR RETURN AND EVALUATION OF THE BLADES. A FOLLOW UP REPORT WILL BE ISSUED IF ONCE THE DISPOSABLES ARE RETURNED FOR EVALUATION.
FOLLOW UP # 1. PITTING AND SURFACE EROSION WAS OBSERVED ON FRAGMENTS FROM BOTH RETURNED SHAVER TIPS, IN THE AREAS ADJACENT TO THE FRACTURE. THIS EROSION IS CONSISTENT WITH CONTACT OF THE TIP WITH SOME FOREIGN BODY, SUCH AS A RETRACTOR OR METALLIC HARDWARE. CONTACT WITH THE TIP WHILE ULTRASONICALLY ACTIVE WILL RESULT IN A HIGHLY ABRASIVE CONDITION. THIS CONTACT LEADS TO DAMAGE TO THE SURFACE CONSISTENT WITH THE OBSERVATIONS. CONTINUED USE UNDER CYCLIC ULTRASONIC AND REPEATED LOAD-INDUCED STRESSES, CREATES STRESS-RISERS AT THESE CONTACT LOCATIONS, AND ULTIMATELY WEAKENS THE TIP TO BELOW ITS FATIGUE-INDUCED YIELD STRESS. PART FAILURE AT THIS POINT BECOMES IMMINENT. THE INVESTIGATION HAS BEEN CONCLUDED.
ON SEPTEMBER 05, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A BONESCALPEL® MICROHOOK DISPOSABLE (PART NUMBER MXB-S1, LOT NUMBER 223305) DURING A LUMBAR FUSION THAT OCCURRED ON (B)(6) 2024. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. SPECIFICALLY, IT WAS REPORTED THAT DURING THE SURGERY THE BLADE BROKE LEAVING A PIECE THAT NEEDED TO BE REMOVED FROM THE WOUND. A NEW BLADE WAS OPENED, AND THE SURGEON EXPERIENCED THE SAME ISSUE.
ON SEPTEMBER 05, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING TWO BONESCALPEL® MICROHOOK DISPOSABLES (PART NUMBER MXB-S1, LOT NUMBER 223305) DURING A LUMBAR FUSION THAT OCCURRED ON (B)(6) 2024. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. SPECIFICALLY, IT WAS REPORTED THAT DURING THE "BLADE BROKE WHEN IN USE BY SURGEON LEAVING A PIECE NEEDING TO BE RECOVERED FROM WOUND. THIS HAPPENED TWO TIMES WITH TWO DIFFERENT BLADES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679817 | BONESCALPEL® MICROHOOK DISPOSABLE | BONESHAVER, MICROHOOK | LFL | MISONIX, INC. | MXB-S1 | 223305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |