BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONESCALPEL 20MM UNILATTERAL SERRATIONS BLADE

    MDR report key: 7809424 · Received August 23, 2018

    Report

    Report Number
    2435119-2018-00010
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    June 14, 2018
    Report Date
    August 23, 2018
    Manufacturer
    MISONIX INC
    Product Code
    LFL
    UDI-DI
    00841626101197
    PMA / PMN Number
    K070313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    MISONIX RECEIVED COMPLAINT (B)(4) FOR A MALFUNCTION OF MXB-B1, LOT# 1058583, REPORTING "TIP BROKE LOSE WHILE OPERATING." A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE A SERIOUS INJURY WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. NO DETAILS OF THE CIRCUMSTANCES OF USE WERE PROVIDED. THEREFORE, WE ARE UNABLE TO VERIFY THE DEVICE WAS USED CONSISTENT WITH THE BONESCALPEL ULTRASONIC SURGICAL SYSTEM INSTRUCTIONS FOR USE AND INDICATIONS FOR USE. NO PATIENT DETAILS WERE PROVIDED. NO DETAILS OF THE CLINICAL HISTORY OR SURGICAL PROCEDURE WERE PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE IF THE DEVICE WAS USED WITHIN THE LABELED INDICATIONS FOR USE OR WHETHER THERE WAS RELEVANT CLINICAL HISTORY. DHR REVIEW: A REVIEW OF THE DHR FOR BONESCALPEL, 20MM, UNILATERAL SERRATIONS, BEARING LOT # 1058583 INDICATES THE LOT WAS RECEIVED ON JUNE 16, 2017 AND ACCEPTED WITHOUT NONCONFORMANCE. IT IS NOTED THAT MXB-B1 IS A STERILE KIT CONTAINING MULTIPLE COMPONENT PARTS. THE BLADE CONTAINED IN THE MXB-B1 STERILE KIT IS (B)(4) BLADE - 20MM. INCOMING INSPECTION RECORDS INDICATE THAT MXB-B1 LOT#1058583 CONTAINED (B)(4) MANUFACTURERS ETCHED LOT# 079. REVIEW OF INCOMING INSPECTION RECORDS FOR THE E4007ABC20 INDICATE THAT THE MANUFACTURER'S LOTS WERE ACCEPTED WITHOUT NONCONFORMANCE. TREND ANALYSIS: ELEVEN (11) BONESCALPEL, 20MM, UNILATERAL SERRATIONS, MXB-B1 WERE RETURNED TO MISONIX FROM JUNE 28, 2017 TO JUNE 28, 2018 WHERE THE SERVICE/ENGINEERING EVALUATION FOUND A BROKEN BLADE PROBLEM. MISONIX HAS SOLD (B)(4) MXB-B1 FROM JUNE 28, 2017 TO JUNE 28, 2018. THE RETURN RATE FOR THIS PROBLEM DURING THE TIME PERIOD INDICATED IS (B)(4) BASED ON THE NUMBER OF UNITS SOLD. THERE ARE (2) OTHER MXB-B1 COMPLAINTS FOR THE REPORTED LOT# 1058583. THE DEFECT RATE FOR THE BLADE LOT 079 IS (B)(4). THIS FREQUENCY IS BELOW THE ESTIMATED FREQUENCY IN OUR RISK MANAGEMENT FILE AND IS CONSIDERED REMOTE. THEREFORE, THERE IS NO CHANGE IN THE ESTIMATED RISK PROBABILITY NUMBER OR RISK/BENEFIT IN OUR RISK MANAGEMENT FILE. ENGINEERING EVALUATION: THE DEVICES WERE RECEIVED AT MISONIX ON JULY 23, 2018 UNDER RMA (B)(4) AND FORWARDED TO ENGINEERING FOR EVALUATION. MISONIX COULD NOT DETERMINE ROOT CAUSE OF THE BLADE BREAK AFTER AN EXTENSIVE INVESTIGATION. IT IS NOTED THAT THERE IS A MISSING FRAGMENT OF THE BROKEN BLADE THAT WAS NOT RETURNED TO MISONIX FOR EVALUATION. WE CANNOT DETERMINE IF THE MISSING FRAGMENT MAY HAVE PROVIDED ADDITIONAL INSIGHT TO CAUSE OF FAILURE. DESIGN CONTROL VERIFICATION TESTING AND LOT RELEASE TESTING INCLUDING BENCH TESTS AND SIMULATED USE TESTS TO ENSURE EACH LOT CAN WITHSTAND MECHANICAL FORCE FROM ULTRASONIC VIBRATION AND APPLIED LOAD UNDER NORMALLY ENCOUNTERED STRESS CONDITIONS. A REVIEW OF THE HISTORY RECORD DURING THE INVESTIGATION INDICATES THE SUBJECT LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. THE PREDOMINANT FAILURE MODE FOR ULTRASONIC BONESCALPEL, 20MM, UNILATERAL SERRATIONS, MXB-B1, THAT BREAK DURING USE IS A PARTIAL OR COMPLETE FRACTURE. THEY TYPICALLY DO NOT SHATTER OR CREATE MULTIPLE IRRETRIEVABLE FRAGMENTS THAT WOULD DIFFICULT TO LOCATE OR REMOVE. THE SYSTEM IS DESIGN TO EMIT A VISUAL AND AUDIBLE "MECHANICAL LIMIT" ALARM WHEN A TIP FRACTURES, COMMUNICATING TO THE USER THE FAULT CONDITION. WHEN THE TIP FRACTURES, TRIGGERING THE "MECHANICAL LIMIT" ALARM, THE DEVICE STOPS ENERGIZING THE HANDPIECE TO WHICH THE TIP IS ATTACHED. 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): 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. CONCLUSION: THE ROOT CAUSE OF THE BLADE BREAK COULD NOT BE DETERMINED. THE FREQUENCY OF BLADE BREAKS IS BELOW THE ORIGINAL FREQUENCY ESTIMATED IN THE PRODUCT RISK ASSESSMENT; THEREFORE, THERE IS NO CHANGE IN RESIDUAL RISK OR RISK BENEFIT. THERE ARE ADEQUATE WARNINGS IN THE INSTRUCTION FOR USE MANUAL REGARDING CONDITIONS OF USE THAT MAY CAUSE OR CONTRIBUTE TO A BLADE BREAK AND PROCEDURE TO FOLLOW IF A BLADE BREAKS. THERE WAS NOT SERIOUS INJURY, NO INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY AND NO DELAY IN TREATMENT REPORTED. NO FURTHER ACTION IS TO BE TAKEN.

    Description of Event or Problem · 1

    CUSTOMER STATED PROBLEM AS "TIP BROKE LOSE WHILE OPERATING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651812 BONESCALPEL 20MM UNILATTERAL SERRATIONS BLADE ULTRASONIC SURGICAL SYSTEM LFL MISONIX INC MXB-B1 1058583 00841626101197

    Patients

    Seq Age Sex Outcome Treatment
    1