BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISONIX BONESCALPEL SYSTEM MXB-10 BLUNT BLADE

    MDR report key: 7071346 · Received November 30, 2017

    Report

    Report Number
    2435119-2017-00008
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    October 17, 2017
    Report Date
    November 29, 2017
    Manufacturer
    MISONIX, INC
    Product Code
    LFL
    UDI-DI
    00841626101104
    PMA / PMN Number
    K070313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MISONIX RECEIVED MEDWATCH MW5072975 ON NOVEMBER 7, 2017 FOR A MALFUNCTION OF MXB-10, LOT# 1030892, REPORTING "TIP OF MISONIX BONE SCALPEL BROKE DURING USE" ON (B)(6) 2017. FACILITY/USER IDENTIFICATION WAS NOT DISCLOSED. REPORTER INDICATED AS A HEALTH PROFESSIONAL. NO DETAILS OF THE CIRCUMSTANCES OF USE WERE PROVIDED. UNABLE TO VERIFY THE DEVICE WAS USED CONSISTENT WITH THE BONESCALPEL ULTRASONIC SURGICAL SYSTEM IFU RECOMMENDATIONS. NO REPORT OF THE USER WAS PROVIDED. UNABLE TO VERIFY THAT IN SERVICE TRAINING WAS PROVIDED PRIOR TO USE. NO PATIENT DETAILS WERE PROVIDED. NO DETAILS OF THE PROCEDURE WERE PROVIDED. UNABLE TO DETERMINE IF THE DEVICE WAS APPROPRIATE FOR THE PROCEDURE. NO MATERIALS WERE RETURNED FOR EVALUATION. DHR REVIEW: A INVESTIGATION WAS PERFORMED BASED ON REPORTED DEVICE AND LOT# REPORTED. A REVIEW OF THE DHR FOR BONESCALPEL, 10MM, BLUNT, MXB 10, BEARING LOT # 1030892 INDICATES THE LOT WAS RECEIVED ON MAY 4, 2017 AND ACCEPTED WITHOUT NONCONFORMANCE. IT IS NOTED THAT MXB-10 IS A STERILE KIT CONTAINING MULTIPLE COMPONENT PARTS. THE TIP CONTAINED IN THE MXB-10 STERILE KIT IS E4003ABC10 BLADE - 10MM. INCOMING INSPECTION RECORDS INDICATE THAT MXB-10 LOT#1030892 CONTAINED E4003ABC10 LOT # 108698 AND 108716. REVIEW OF INCOMING INSPECTION RECORDS FOR THE E4003ABC10 INDICATE THAT THE MANUFACTURER'S LOTS WERE ACCEPTED WITHOUT NONCONFORMANCE. MISONIX HAS SOLD (B)(4) MXB-10 FROM OCTOBER 17, 2016 TO OCTOBER 17, 2017. TREND ANALYSIS: TWO (2) BONESCALPEL, 10MM, BLUNT, MXB 10 WERE RETURNED TO MISONIX FROM OCTOBER 17, 2016 THROUGH OCTOBER 17, 2017 WHERE THE SERVICE/ENGINEERING EVALUATION FOUND A BROKEN BLADE PROBLEM. REVIEW OF THE SPECIFICS SURROUNDING THE DETAILS DOES NOT INVOLVE ANY OTHER REPORTS OF MALFUNCTION. THE RETURN RATE FOR THIS PROBLEM DURING THE TIME PERIOD INDICATED ABOVE IS 0.03%. THERE ARE NO MXB-10 COMPLAINT RETURNS FOR THE REPORTED LOT#1030892. ENGINEERING EVALUATION: RMA REQUESTS WERE REVIEWED FOR THE PRODUCT AND SPECIFIED LOT, AS REPORTED, AND NO OTHER REPORT FROM USERS, DISTRIBUTORS OR INTERNAL REPRESENTATIVES WERE FOUND TO EXIST. NO MATERIAL WAS RETURNED. AN ENGINEERING EVALUATION COULD NOT BE PERFORMED. THE PREDOMINANT FAILURE MODE FOR ULTRASONIC BONESCALPEL, 10MM, BLUNT, BLADES THAT BREAK DURING USE IS A PARTIAL OR COMPLETE FRACTURE. THEY TYPICALLY DO NOT SHATTER OR CREATE MULTIPLE UNRETRIEVABLE FRAGMENTS THAT WOULD DIFFICULT TO LOCATE OR REMOVE. THE MEDWATCH REPORTED THAT THE BONESCALPEL, 10MM, BLUNT, BLADE TIP BROKE OFF DURING USE. BECAUSE THE SURGICAL PROCEDURE IS PERFORMED UNDER SURGEON'S DIRECT VISUALIZATION AND ENHANCED BY LOUPE FITTED EYEGLASSES OR A MICROSCOPE, THE INSTRUMENT FAILURE CAN BE PROMPTLY IDENTIFIED. FURTHERMORE, THE SYSTEM IS DESIGN TO EMIT "MECHANICAL LIMIT" ALARMS WHEN THE TIPS FRACTURE, FURTHER COMMUNICATING TO THE USER THAT SOMETHING ABNORMAL HAS OCCURRED. WHEN THE TIP FRACTURES, TRIGGERING THE "MECHANICAL LIMIT" ALARM, THE DEVICE STOPS ENERGIZING THE HANDPIECE TO WHICH THE TIP IS ATTACHED. THE BROKEN PIECES CAN BE EASILY VISUALLY IDENTIFIED, IN SOME CASES AIDED BY THE USE OF ENHANCED VISUALIZATION BY ROUTINE LOUPE FITTED EYEGLASSES OR MICROSCOPES AND REMOVED FROM THE SURGICAL FIELD. SURGICAL SUITES TYPICALLY HAVE ACCESS TO X RAY EQUIPMENT AND WOULD BE ABLE TO QUICKLY IDENTIFY AND LOCATE ANY FRAGMENTS NOT FOUND BY DIRECT OR ENHANCED VISUALIZATION BY USING SUCH EQUIPMENT. THE FRACTURED PIECE CAN THEREFORE BE FOUND AND EXTRACTED QUICKLY AND EASILY WITHOUT SIGNIFICANT DELAY IN THE SURGICAL PROCEDURE. THE TIPS ARE SHIPPED AS STERILE COMPONENTS IN MULTIPLE PACKAGES; THEREFORE THE TIP CAN REPLACED WITH A NEW ONE WITHOUT SIGNIFICANT DELAY IN THE SURGICAL PROCEDURE. IN THE EVENT THAT THE BONESCALPEL COULDN'T BE USED TO COMPLETE THE PROCEDURE SURGICAL SUITES HAVE ACCESS TO ALTERNATIVE TECHNOLOGIES THAT CAN BE USED TO COMPLETE THE SURGICAL PROCEDURE WITHOUT SIGNIFICANT DELAY IN TREATMENT. THE PRODUCT IFU (BCM-UM, REVISION P) CONTAINS THE FOLLOWING WARNING(S): CAUTION 7.7: THE SYSTEM CHECK SHOULD ALWAYS BE DONE IN ADVANCE OF PREPARING PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. WARNING 1.2: 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 4.4 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. WARNING 4.3 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. IN ADDITION, DURING SURGERY, OTHER METAL MEDICAL DEVICES ARE USED. CONTACT OF THE ULTRASONIC TIP WITH OTHER METAL DEVICES DURING SURGERY CAN DAMAGE THE ULTRASONIC TIP AND CAUSE FRACTURE. THE PRODUCT IFU CONTAINS THE FOLLOWING NOTE: NOTE 4.3 CONTACT OF THE ULTRASONIC TIP OR 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 OF THE PROBE TIP. CONCLUSION: BASED ON THE INFORMATION PROVIDED, THERE DOES NOT APPEAR TO BE A MALFUNCTION OF THE DEVICE THAT CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. THERE IS NO DEFINITIVE ROOT CAUSE. A POTENTIAL ROOT CAUSE IS THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH MANUFACTURER RECOMMENDATIONS.

    Description of Event or Problem · 1

    THIS REPORT IS IN RESPONSE TO MEDWATCH REPORT MW5072975 RECEIVED BY MISONIX, INC ON (B)(6) 2017 VIA US POSTAL SERVICE. MEDWATCH REPORTS THAT A MISONIX BONESCALPEL ULTRASONIC SYSTEM MXB-10 BLADE TIP BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849214 MISONIX BONESCALPEL SYSTEM MXB-10 BLUNT BLADE ULTRASONIC SURGICAL SYSTEM LFL MISONIX, INC 1030892 00841626101104

    Patients

    Seq Age Sex Outcome Treatment
    1