BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONESCALPEL® BONESHAVER, MICROHOOK DISPOSABLE

    MDR report key: 20768686 · Received November 24, 2024

    Report

    Report Number
    2435119-2024-00043
    Event Type
    Malfunction
    Date Received
    November 24, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 24, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K070313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 25, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A BONESCALPEL® BONESHAVER, MICROHOOK DISPOSABLE (PART NUMBER MXB-S1, LOT NUMBER 243070) THAT OCCURRED ON (B)(6) 2024, DURING AN ACDF DECOMPRESSION. SPECIFICALLY, IT WAS REPORTED THAT A "SHORT PERIOD INTO THE SURGERY THE MXB-S1 BROKE OFF BY THE THREAD." A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. DELAY IN TREATMENT WAS REPORTED TO OPEN AND ASSEMBLY ANOTHER DISPOSABLE TIP. 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 SUBJECT DISPOSABLE HAS NOT YET BEEN RETURNED FOR EVALUATION; THEREFORE, A THOROUGH INVESTIGATION COULD NOT BE CONDUCTED AS OF THE TIME OF THIS REPORT. HOWEVER, A PHOTO WAS PROVIDED WHICH CONFIRMED THE DISPOSABLE BROKE WHERE THE PROBE THREAD IS ASSEMBLED INTO THE EXTENSION OF THE DISPOSABLE HORN. UPON RETURN, A FULL EVALUATION WILL BE COMPLETED TO ESTABLISH POTENTIAL ROOT CAUSE, AND A FOLLOW UP REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ON OCTOBER 25, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF AN EVENT INVOLVING A BONESCALPEL® BONESHAVER, MICROHOOK DISPOSABLE (PART NUMBER MXB-S1, LOT NUMBER 243070) THAT OCCURRED ON (B)(6) 2024, DURING AN ACDF DECOMPRESSION. SPECIFICALLY, IT WAS REPORTED THAT A "SHORT PERIOD INTO THE SURGERY THE MXB-S1 BROKE OFF BY THE THREAD." A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED. DELAY IN TREATMENT WAS REPORTED TO OPEN AND ASSEMBLY ANOTHER DISPOSABLE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213889 BONESCALPEL® BONESHAVER, MICROHOOK DISPOSABLE BONESHAVER, MICROHOOK LFL MISONIX, INC. MXB-S1 243070

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other