BONESCALPEL® BONESHAVER, DIAMOND, Ø4.44MM
Report
- Report Number
- 2435119-2022-00005
- Event Type
- Malfunction
- Date Received
- May 26, 2022
- Date of Event
- April 5, 2022
- Report Date
- February 11, 2025
- Manufacturer
- MISONIX, INC.
- Product Code
- LFL
- PMA / PMN Number
- K070313
- Removal / Correction Number
- 2435119-2022-00005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- 003
Narratives
ON MAY 12, 2022, MISONIX RECEIVED A PRODUCT OCCURRENCE REPORT ON A BONESCALPEL® BONESHAVER, DIAMOND, Ø4.44MM (PART NUMBER MXB-S3, LOT NUMBER 213296) THAT OCCURRED ON (B)(6) 2022, DURING AN ANTERIOR CERVICAL SURGERY. DURING THE PROCEDURE THE DIAMOND, STANDARD SHAVER BROKE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, THERE WAS A DELAY IN TREATMENT GREATER THAN 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE BONESCALPEL® BONESHAVER, DIAMOND, Ø4.44MM (PART NUMBER MXB-S3, LOT NUMBER 213296) INVOLVED IN THE EVENT. LOT #213296 WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. INSPECTION AND TEST RESULTS MET SPECIFICATIONS. THERE WERE NO DEVIATIONS OR EXCEPTIONS NOTED. A REVIEW OF ALL AVAILABLE POST-MARKET SURVEILLANCE INFORMATION INVOLVING THIS PRODUCT AND LOT NUMBER FOR BLADE BREAKAGES DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS. 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. 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 BONESCALPEL® IFU (BCM-UM, REVISION U) CONTAINS 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 TIPS CAN BREAK UNDER EXCESSIVE USE IN EXTREME CONDITIONS, E.G. WHEN CUTTING FOR EXTENDED DURATION IN TIGHT CAVITIES WITH LIMITED LATERAL MOTION. THE 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. TIPS CAN BEND OR DEFORM BEFORE THEY ACTUALLY BREAK. TIPS SHOWING SIGNS OF DEFORMATION OR CRACKING SHOULD BE REPLACED IMMEDIATELY SINCE TIP BREAKAGE IS OTHERWISE IMMINENT. DO NOT BEND OR TWIST THE ULTRASONIC TIPS SINCE IT REDUCES THE STRUCTURAL INTEGRITY AND CAN RESULT IN TIP BREAKAGE DURING USE. DISPOSE OF DEFORMED OR BROKEN TIPS IMMEDIATELY IN A SHARPS CONTAINER. CAUTION 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 TIPS THAT SHOW SIGNS OF DAMAGES LIKE GOUGES, NICKS OR FRACTURES. EXTERNAL ASPIRATION MAY BE USED BUT IT IS RECOMMENDED THAT A PLASTIC SUCTION TIP SHOULD BE USED WHEN IN PROXIMITY WITH THE PROBE TIP. THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED TO MISONIX FOR EVALUATION, THEREFORE A THOROUGH INVESTIGATION COULD NOT BE CONDUCTED. UPON RETURN A FULL ENGINEERING EVALUATION WILL BE COMPLETED TO ESTABLISH POSSIBLE ROOT CAUSE OF THE NON-CONFORMANCE.
FOLLOW UP # 1: THE BONESCALPEL® BONESHAVER, DIAMOND, Ø4.44MM (PART NUMBER MXB-S3 IS A STERILE KIT CONTAINING MULTIPLE COMPONENT PARTS. THE SUBJECT DIAMOND BONE SHAVER (PART NUMBER E4004ABC30) WAS RETURNED TO MISONIX FOR EVALUATION. THE PITTING AND SURFACE ABRASION WOULD LIKELY INDICATE CONTACT OF THE TIP WITH SOME FOREIGN BODY SITUATED WITHIN THE SURGICAL FIELD, SUCH AS A RETRACTOR, METALLIC HARDWARE, OR POSSIBLE OTHER BONY STRUCTURES. CONTACT WITH THE TIP WITH HARD MATERIALS WHILE ULTRASONICALLY ACTIVE WILL RESULT IN A HIGHLY ABRASIVE CONDITION. THIS LEADS TO SURFACE DAMAGE CONSISTENT WITH THE OBSERVATIONS, WHICH ULTIMATELY WEAKENS THE TIP TO BELOW ITS FATIGUE-INDUCED YIELD STRESS, AFTER WHICH PART FAILURE IS IMMINENT. THE INVESTIGATION HAS BEEN CONCLUDED.
ON MAY 12, 2022, MISONIX RECEIVED A PRODUCT OCCURRENCE REPORT ON A BONESCALPEL® BONESHAVER, DIAMOND, Ø4.44MM (PART NUMBER MXB-S3, LOT NUMBER 213296) THAT OCCURRED ON (B)(6) 2022, DURING AN ANTERIOR CERVICAL SURGERY. DURING THE PROCEDURE THE DIAMOND, STANDARD SHAVER BROKE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, THERE WAS A DELAY IN TREATMENT GREATER THAN 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED.
ON MAY 12, 2022, MISONIX RECEIVED A PRODUCT OCCURRENCE REPORT ON A BONESCALPEL® BONESHAVER, DIAMOND, Ø4.44MM (PART NUMBER MXB-S3, LOT NUMBER 213296) THAT OCCURRED ON (B)(6) 2022, DURING AN ANTERIOR CERVICAL SURGERY. DURING THE PROCEDURE THE DIAMOND, STANDARD SHAVER BROKE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED; HOWEVER, THERE WAS A DELAY IN TREATMENT GREATER THAN 15 MINUTES. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285241 | BONESCALPEL® BONESHAVER, DIAMOND, Ø4.44MM | ULTRASONIC SURGICAL SYSTEM DISPOSABLE | LFL | MISONIX, INC. | MXB-S3 | 213296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |