BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONESCALPEL 10MM BLUNT

    MDR report key: 7764175 · Received August 8, 2018

    Report

    Report Number
    2435119-2018-00008
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    July 13, 2018
    Report Date
    September 28, 2018
    Manufacturer
    MISONIX INC
    Product Code
    LFL
    UDI-DI
    00841626101104
    PMA / PMN Number
    K070313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT: (B)(4) FOLLOW-UP 001 MANUFACTURERS NARRATIVE. ENGINEERING EVALUATION: THE COMPLAINT SAMPLE WAS RECEIVED AT MISONIX ON AUGUST 30, 2018 UNDER: RMA 36332. THREE PARTS WERE RETURNED TO MISONIX FOR EVALUATION: A 10MM HORN, A 10MM BLADE AND A SILICONE SHEATH. A VISUAL INSPECTION WAS CONDUCTED. THE 10MM BLADE WAS OBSERVED WITH A FRACTURED SEGMENT MISSING AT THE DISTAL TIP, LATERAL TO THE CENTERLINE. NO OTHER DEFECTS WERE NOTED FOR THE BLADE. THE RESULTS OF THE VISUAL INSPECTION OF THE HORN AND SILICONE SHEATH CONFORMED TO ALL ATTRIBUTE SPECIFICATIONS. NO DEFECTS WERE NOTED. THE 10MM BLADE WAS OBSERVED UNDER MAGNIFICATION. SIGNIFICANT DISCOLORATION WAS NOTED ON THE MAJORITY OF BOTH BLADE SURFACES. IN ADDITION, THE SEGMENT OF BLADE PROXIMAL TO THE FRACTURE LOCATION WAS SIGNIFICANTLY DEFORMED. BASED ON THE OBSERVATIONS, THE TIP WAS LIKELY SUBJECTED TO INTENSE LOADING AND BENDING OR TWISTING FORCES WHILE ENGAGED IN TISSUE. THE DEFORMED SEGMENT DIRECTLY PROXIMAL TO THE FAILURE IS LIKELY THE STRAIN THAT ULTIMATELY CAUSED EXCESSIVE STRESSES LEADING TO FRACTURE. THE PRODUCT IFU (BCM-UM, REVISION R) CONTAINS THE FOLLOWING WARNING(S): 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.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TO FDA ON UF REPORT# (B)(4), "DURING USE OF THE ULTRASONIC BONE SCALPEL DURING A NEUROLOGICAL SURGERY CASE, A SECTION OF THE 10MM BLUNT BLADE BROKE OFF NEAR THE DISTAL END OF THE BLADE AND SEPARATED FROM THE BLADE. THE WOUND, SPONGES, COLLECTED BONE WERE SEARCHED WELL AS X-RAY IMAGES TO RETRIEVE BROKEN SECTION OF THE BLADE. INSTRUMENT FRAGMENT WAS NOT LOCATED AND SURGEON DECIDED TO CLOSE WOUND. CASE COMPLETED WITH NO ADDITIONAL COMPLICATIONS. BROKEN BONE SCALPEL AND ACCESSORIES WERE SEQUESTERED AND DELIVERED TO BIOMEDICAL FOR REPORTING AND DELIVERY TO MANUFACTURER."

    Additional Manufacturer Narrative · 1

    MISONIX RECEIVED MEDWATCH REFERENCE UF/IMPORTER (B)(4) ON JULY 19, 2018 FOR A MALFUNCTION OF MXB-10, LOT# 1117972, REPORTING "DURING USE OF THE ULTRASONIC BONE SCALPEL DURING A NEUROLOGICAL SURGERY CASE, A SECTION OF THE 10 MM BLUNT BLADE BROKE OFF NEAR THE DISTAL END OF THE BLADE AND SEPARATED FROM THE BLADE. THE WOUND, SPONGES, COLLECTED BONE WERE SEARCHED WELL AS X-RAY IMAGES TO RETRIEVE BROKEN SECTION OF THE BLADE. INSTRUMENT FRAGMENT WAS NOT LOCATED AND SURGEON DECIDED TO CLOSE WOUND. CASE COMPLETED WITH NO ADDITIONAL COMPLICATIONS. BROKEN BONE SCALPEL AND ACCESSORIES WERE SEQUESTERED AND DELIVERED TO BIOMEDICAL FOR REPORTING AND DELIVERY TO MANUFACTURER." FACILITY/USER IDENTIFICATION WAS DISCLOSED AS (B)(4) HOSPITAL, (B)(4). REPORTER INDICATED AS A HEALTH PROFESSIONAL. PATIENT INDICATED AS A (B)(6) NON-HISPANIC FEMALE. THE USER FACILITY STATED THAT THERE WERE NO COMPLICATIONS. THEREFORE, THIS EVENT IS NOT AN ADVERSE EVENT. IT IS A MALFUNCTION. NO RELEVANT HISTORY WAS REPORTED. THE USE OF OTHER PRODUCTS WAS NOT REPORTED. THE DEVICE SETTINGS DURING THE PROCEDURE WERE NOT REPORTED. THEREFORE, WE ARE NOT ABLE TO DETERMINE IF THE DEVICE USE WAS CONSISTENT WITH THE BONESCALPEL INDICATIONS OR INSTRUCTIONS FOR USE. NO REPORT OF THE SPECIFIC USER WAS PROVIDED. THEREFORE, WE ARE UNABLE TO VERIFY THAT IN SERVICE TRAINING WAS PROVIDED PRIOR TO USE. THE BLADE SUBJECT OF THIS EVENT WAS NOT RETURNED FOR EVALUATION AS OF THIS FILING. DHR REVIEW: AN INVESTIGATION WAS PERFORMED BASED ON REPORTED DEVICE PART# AND LOT#. 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 - 10 MM. REVIEW OF INCOMING INSPECTION RECORDS FOR JULY 23, 2017 THROUGH JULY 23, 2018 FOR THE MXB-10 INDICATE THAT THE LOT# 1117972 MET ACCEPTANCE CRITERIA. FURTHER REVIEW OF THE INCOMING INSPECTION RECORDS FOR THE COMPONENT BLADE E4003ABC10 INDICATES THAT THE LOT MET ACCEPTANCE CRITERIA. MISONIX HAS SOLD (B)(4) MXB-10 FROM JULY 23, 2017 TO JULY 23, 2018. TREND ANALYSIS: INCLUDING THIS REPORTED ITEM, FIVE (5) BONESCALPEL, 10 MM, BLUNT, MXB-10 WERE RETURNED TO MISONIX FROM JULY 23, 2017 TO JULY 23, 2018 WHERE THE SERVICE/ENGINEERING EVALUATION FOUND A BROKEN OR DAMAGED BLADE PROBLEM. REVIEW OF THE SPECIFICS SURROUNDING THE DETAILS DOES NOT INVOLVE ANY OTHER REPORTS OF MALFUNCTION. THE INVESTIGATION OF THE FIVE (5) REPORTS OF BROKEN BLADES DID NOT RESULT IN A CONCLUSION THAT THE ROOT CAUSE WAS RELATED TO A DESIGN OR MANUFACTURING ISSUE. THE RETURN RATE FOR THIS PROBLEM DURING THE TIME PERIOD INDICATED ABOVE IS 0.05%. BASED ON OUR RISK MANAGEMENT SYSTEM, THIS RATE OF OCCURRENCE IS REMOTE (<1%) AND WELL BELOW THE ORIGINAL ESTIMATED RISK PROBABILITY NUMBER AND RISK/BENEFIT RATIO IN THE ORIGINAL DESIGN RISK ASSESSMENT. ENGINEERING EVALUATION: NO MATERIAL WAS RETURNED. AN ENGINEERING EVALUATION COULD NOT BE PERFORMED. THE PREDOMINANT FAILURE MODE FOR ULTRASONIC BONESCALPEL, 10 MM, BLUNT, BLADES THAT BREAK DURING USE IS A PARTIAL OR COMPLETE FRACTURE. THEY TYPICALLY DO NOT SHATTER OR CREATE MULTIPLE UN-RETRIEVABLE FRAGMENTS THAT WOULD BE DIFFICULT TO LOCATE OR REMOVE. THE MEDWATCH REPORTED THAT THE BONESCALPEL, 10 MM, 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 DESIGNED 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 BE 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 R) 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO FDA ON UF REPORT (B)(4), "DURING USE OF THE ULTRASONIC BONE SCALPEL DURING A NEUROLOGICAL SURGERY CASE, A SECTION OF THE 10 MM BLUNT BLADE BROKE OFF NEAR THE DISTAL END OF THE BLADE AND SEPARATED FROM THE BLADE. THE WOUND, SPONGES, COLLECTED BONE WERE SEARCHED WELL AS X-RAY IMAGES TO RETRIEVE BROKEN SECTION OF THE BLADE. INSTRUMENT FRAGMENT WAS NOT LOCATED AND SURGEON DECIDED TO CLOSE WOUND. CASE COMPLETED WITH NO ADDITIONAL COMPLICATIONS. BROKEN BONE SCALPEL AND ACCESSORIES WERE SEQUESTERED AND DELIVERED TO BIOMEDICAL FOR REPORTING AND DELIVERY TO MANUFACTURER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601827 BONESCALPEL 10MM BLUNT ULTRASONIC SURGICAL SYSTEM BLADE LFL MISONIX INC MXB-10 1117972 00841626101104

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR