BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONASTAR OSTEOSCULPT TIP WITH ASPIRATION 1.1MM LONG CURVED SHAVER, STERILE

    MDR report key: 8756036 · Received July 2, 2019

    Report

    Report Number
    2435119-2019-00002
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 2, 2019
    Manufacturer
    MISONIX INC
    Product Code
    LFL
    UDI-DI
    00841626100510
    PMA / PMN Number
    K062471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    MISONIX RECEIVED COMPLAINT (B)(4) ON JUNE 6, 2019, FOR A MALFUNCTION OF MXA-S004, LOT# 713746, REPORTING "DURING A SURGERY PERFORMED AT (B)(6) BY DR. (B)(6), WHILE USING THE SONASTAR BONE CUSA, ASPIRATION TIP MXA-S004 LOT. 713746, THIS BROKE AT ITS EDGE AND NOT AS A RESULT OF EXCESS PRESSURE APPLIED BY THE USER AND THE PIECE FELL INTO THE WOUND. FORTUNATELY THEY WERE ABLE TO REMOVE IT WITH A FORCEP. THEY HAVE THEN CHANGED THE TIP AND THE SURGERY CONTINUED, WITHOUT ANY IMPACT ON THE PATIENT." THE DEVICE WAS RECEIVED AT MISONIX FOR EVALUATION ON JUNE 18, 2019. DHR REVIEW: MXA-S004 IS A STERILE KIT CONTAINING MULTIPLE COMPONENT PARTS. THE REPORTED LOT# 713746 IS FOR THE STERILE KIT OF MXA-S004. THE CUSTOMER RETURNED 1 DAMAGED [TIP - SHAVER LC] [PART #CFSM2-N140] WITH MANUFACTURER'S ETCHED LOT # CMS-0136. A REVIEW OF INCOMING INSPECTION RECORDS FOR THE MXA-S004 LOT# 713746 INDICATES MISONIX RECEIVED 95 ITEMS FROM THE VENDOR ON FEBRUARY 06, 2019 AND 19 WERE INSPECTED ACCORDING TO C=0 INSPECTION PROTOCOL. SAMPLE #18 HAD A PARTICULATE ON THE SIDE OF THE BLISTER TRAY. ALL OTHER MATERIAL MET SPECIFICATION AND WERE ACCEPTED. (REFERENCE RECEIPT (B)(4)). A REVIEW OF INCOMING INSPECTION RECORDS FOR THE RETURNED TIP CFSM2-N140 COMPONENT (REFERENCE RECEIPT (B)(4).) INCLUDED IN MXA-S004 LOT# 713746 INDICATES THAT THE MATERIAL MET SPECIFICATION AND WERE ACCEPTED. MISONIX HAS SHIPPED/SOLD 294 MXA-S004 BETWEEN JUNE 01, 2018 AND MAY 31, 2019. TREND ANALYSIS: THIS IS THE ONLY COMPLAINT FOR A SONASTAR OSTEOSCULPT TIP WITH ASPIRATION 1.1MM LONG CURVED SHAVER, STERILE, MXA-S004 RETURNED TO MISONIX FROM JUNE 07, 2018 THROUGH JUNE 07, 2019 WHERE THE SERVICE/ENGINEERING EVALUATION FOUND A BROKEN TIP 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 (B)(4). THE COMPLAINT DEFECT RATE IS BELOW THE RATE ESTIMATED IN THE ORIGINAL RISK ASSESSMENT; THEREFORE, THERE IS NO CHANGE IN RISK PROBABILITY, RESIDUAL RISK, OR RISK-BENEFIT RATIO. ENGINEERING EVALUATION: EVIDENCE OF HEAVY LOADING WAS OBSERVED ON THE TOP (PROXIMAL OUTER EDGE) OF THE SHAVER TIP, INDICATING HEAVY UPWARDS LOADING CONSISTENT WITH SURGICAL ELEVATION UNDER HIGH FORCE. THE FRACTURE IS LOCATED AT THE PRE-ASPIRATION HOLES WHICH IS CONSISTENT WITH TENSILE FAILURE DUE TO COMBINED ULTRASONIC AND TENSILE LOADS GENERATED BY THE AFOREMENTIONED, HEAVY, UPWARDS LOADING. THE PREDOMINANT FAILURE MODE FOR SONASTAR OSTEOSCULPT TIP WITH ASPIRATION 1.1MM LONG CURVED SHAVER, STERILE, MXA-S004 , TIPS THAT BREAK DURING USE IS A PARTIAL OR COMPLETE FRACTURE. THEY TYPICALLY DO NOT SHATTER OR CREATE MULTIPLE IRRETRIEVABLE FRAGMENTS THAT WOULD BE DIFFICULT TO LOCATE OR REMOVE. THE USER REPORTED THAT THE DEVICE 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 ALARMS WHEN THE TIPS FRACTURE, FURTHER COMMUNICATING TO THE USER THAT SOMETHING ABNORMAL HAS OCCURRED. WHEN THE TIP FACTURES, TRIGGERING 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 SONASTAR SYSTEM 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. CONCLUSION: BASED ON THE EVALUATION OF THE RETURNED PRODUCT, 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. THIS EVENT IS BEING REPORTED TO THE US FDA BECAUSE THE USER STATED IF THE MALFUNCTION WERE TO REOCCUR IT "WOULD BE LIKELY TO CAUSE OR CONTRIBUTE" TO A SERIOUS INJURY. MISONIX FOUND NO MALFUNCTION, THEREFORE NOT LIKELY TO CAUSE A SERIOUS INJURY.

    Description of Event or Problem · 1

    CUSTOMER STATED PROBLEM WAS "DURING A SURGERY PERFORMED AT (B)(6) BY DR. (B)(6), WHILE USING THE SONASTAR BONE CUSA, ASPIRATION TIP MXA-S004 LOT. 713746, THIS BROKE AT ITS EDGE AND NOT AS A RESULT OF EXCESS PRESSURE APPLIED BY THE USER AND THE PIECE FELL INTO THE WOUND. FORTUNATELY THEY WERE ABLE TO REMOVE IT WITH A FORCEP. THEY HAVE THEN CHANGED THE TIP AND THE SURGERY CONTINUED, WITHOUT ANY IMPACT ON THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550051 SONASTAR OSTEOSCULPT TIP WITH ASPIRATION 1.1MM LONG CURVED SHAVER, STERILE ULTRASONIC SURGICAL SYSTEM LFL MISONIX INC MXB-S004 713746 00841626100510

    Patients

    Seq Age Sex Outcome Treatment
    1