BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONESCALPEL-MICRO HOOK, LONG CURVED RIGID SHAVER

    MDR report key: 8158065 · Received December 12, 2018

    Report

    Report Number
    2435119-2018-00014
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    October 11, 2018
    Report Date
    December 12, 2018
    Manufacturer
    MISONIX INC
    Product Code
    LFL
    UDI-DI
    00841626101999
    PMA / PMN Number
    K070313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MISONIX RECEIVED COMPLAINT (B)(4) FOR A MALFUNCTION OF BONESCALPEL-MICRO HOOK, LONG CURVED RIGID SHAVER MXB-MIS-S1, LOT# 1317661, REPORTING "THE DISPOSABLE HEATED UP TO THE POINT OF CREATING A THERMAL BURN THROUGH THE BLACK CONE ON OPEN TISSUE DURING THE CASE. THE TISSUE WAS AN ASHY BLACK COLOR AFTERWARD. THE BLACK NOSE CONE DIDN'T SHOW SIGNED OF MELTING." THE BURN DID NOT CAUSE PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE. NO MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE. NO DELAY IN TREATMENT WAS REPORTED. PATIENT INFORMATION AND CLINICAL HISTORY WAS NOT PROVIDED. DHR REVIEW: BONESCALPEL-MICRO HOOK, LONG CURVED RIGID SHAVER MXB-MIS-S1, LOT# 1317661 INDICATES THE LOT WAS ACCEPTED WITHOUT NONCONFORMANCE. IT IS NOTED THAT DHR FOR BONESCALPEL-MICRO HOOK, LONG CURVED RIGID SHAVER MXB-MIS-S1 IS A STERILE KIT CONTAINING MULTIPLE COMPONENT PARTS. THE BLADE CONTAINED IN THE DHR FOR BONESCALPEL-MICRO HOOK, LONG CURVED RIGID SHAVER MXB-MIS-S1 STERILE KIT IS E4004ABC20 MICROHOOK AND E4106ABC06 HORN. INCOMING INSPECTION RECORDS INDICATE THAT DHR FOR BONESCALPEL-MICRO HOOK, LONG CURVED RIGID SHAVER MXB-MIS-S1, LOT# 1317661 CONTAINED E4004ABC20 MICROHOOK WITH MANUFACTURER'S ETCHED LOT# 116 AND E4106ABC06 HORN WITH MANUFACTURERS ETCHED LOT# R00140418. REVIEW OF INCOMING INSPECTION RECORDS FOR THESE COMPONENTS INDICATE THAT THE MANUFACTURER'S LOTS WERE ACCEPTED WITHOUT NONCONFORMANCE. TREND ANALYSIS: TWO (2) BONESCALPEL-MICRO HOOK, LONG CURVED RIGID SHAVER MXB-MIS-S1, INCLUDING THE SUBJECT COMPLAINT, WERE RECEIVED BY MISONIX FROM NOVEMBER 14, 2017 TO NOVEMBER 14, 2018. THIS IS THE FIRST COMPLAINT OF MXB-MIS-S1 LOT# 1317661, AND THE ONLY COMPLAINT OF MXB-MIS-S1 CAUSING A BURN. MISONIX HAS SOLD (B)(4) BONESCALPEL-MICRO HOOK, LONG CURVED RIGID SHAVER MXB-MIS-S1 FROM NOVEMBER 2017 TO OCTOBER 2018. THE TOTAL DEFECT RATE OF (B)(4) INDICATES THE FREQUENCY IS BELOW THE ESTIMATED FREQUENCY IN OUR RISK MANAGEMENT FILE AND IS CONSIDERED REMOTE. THE DEFECT RATE FOR PATIENT TISSUE BURN IS (B)(6), ALSO BELOW THE ESTIMATED FREQUENCY IN OUR FISK MANAGEMENT FILE. THEREFORE, THERE IS NO CHANGE IN THE ESTIMATED RISK PROBABILITY NUMBER OR RISK/BENEFIT RATIO IN OUR RISK MANAGEMENT FILE. ENGINEERING EVALUATION: THE COMPONENT DEVICES WERE RECEIVED AT MISONIX ON NOVEMBER 19, 2018 UNDER (B)(4) AND FORWARDED TO ENGINEERING FOR EVALUATION. RETURNED COMPONENTS PARTS INCLUDED THE RIGID SHEATH (E0823ABC06), FRONT HOUSING (E0812BBC06), MICROSHAVER TIP (E4004ABC20) AND 20MMHORN WITH NODAL ISOLATOR (E4106ABC06). TECHNICAL EVALUATION INDICATED THE INNER WALL OF THE RIGID SHEATH EXHIBITS DEFORMATION CONSISTENT WITH AN IMPINGEMENT EVENT. THIS MAY HAVE OCCURRED DURING ABNORMALLY HEAVY SIDE LOADING. THE MICROHOOK AND HORN WERE RETURNED WITH BROKEN THREADS, AND NO FURTHER TESTING COULD BE PERFORMED. THE SILICONE SHEATH (E4019ABC06) WAS NOT RETURNED. THESE ARTIFACTS WOULD SUPPORT THE CONCLUSION THAT THE MICROHOOK WAS SUBJECT TO EXCESSIVE STRESSES DURING USE. THE PRODUCT IFU (BCM-UM, REVISION R) CONTAINS THE FOLLOWING WARNING(S): WARNING 3.1: TIP AND IRRIGANT TEMPERATURES MAY EXCEED THE TISSUE NECROSIS POINT IF INSUFFICIENT IRRIGATION FLOW RATES ARE USED. FOR HARD TISSUE REMOVAL, SET THE IRRIGATION FLOWRATE TO A SETTING NO LESS THAN THE COMPARABLE VIBRATION SETTING. FOR EXAMPLE, IF THE VIBRATION SETTING IS 7, A MINIMUM FLOW SETTING OF 70% SHOULD BE USED. ADDITIONAL EXTERNAL IRRIGATION, E.G. BY ADMINISTERING STERILE SALINE WITH A SYRINGE OVER THE DISTAL TIP PORTION, MAY BE NECESSARY FOR REMOVAL OF VERY DENSE, HARD OSSEOUS STRUCTURES. WARNING 3.2: TISSUE NECROSIS MAY RESULT IF TIP IS NOT MOVED RELATIVE TO TISSUE. A CONTINUOUS, LATERAL SWEEPING MOTION IS RECOMMENDED IN ORDER TO MINIMIZE CONTACT DURATION WITH THE ULTRASONIC TIP AND MINIMIZE HEAT BUILD-UP. WHEN LATERAL MOTION IS NOT POSSIBLE WITHDRAW AND RE-INSERT TIP FREQUENTLY. WARNING 3.3: TISSUE NECROSIS MAY RESULT IF TIP IS NOT MOVED RELATIVE TO TISSUE. A CONTINUOUS, LATERAL SWEEPING MOTION IS RECOMMENDED IN ORDER TO MINIMIZE CONTACT DURATION WITH THE ULTRASONIC TIP AND MINIMIZE HEAT BUILD-UP. WHEN LATERAL MOTION IS NOT POSSIBLE WITHDRAW AND RE-INSERT TIP FREQUENTLY. WARNING 4.1: CONTACT TO VIBRATING ELEMENTS LIKE EXTENSION AND ULTRASONIC TIP MAY CAUSE BURNS AND SHOULD BE AVOIDED BY ALL MEANS. THE HANDPIECE SHOULD ONLY BE HELD AT THE BLACK HOUSING AREA. AN OPTIONAL, PROTECTIVE SILICONE SLEEVE, INCLUDED WITH CERTAIN TIPS, REDUCES THE RISK OF THERMAL DAMAGE BUT DOES NOT ELIMINATE IT. CONTACT WITH THE SILICONE SLEEVE SHOULD BE AVOIDED OR KEPT BRIEF WITH MINIMAL AMOUNT OF CONTACT PRESSURE. PRESSURE AND EXTENDED EXPOSURE CAN STILL RESULT IN EXCESSIVE FRICTIONAL HEAT AND CAUSE BURNS. WARNING 7.3: HEAT IS BEING GENERATED AT THE TIP/TISSUE INTERFACE. A CONTINUOUS, LATERAL SWEEPING MOTION IS RECOMMENDED FOR GENERAL BONE/TISSUE REMOVAL IN ORDER TO MINIMIZE CONTACT DURATION WITH THE ULTRASONIC TIP AND MINIMIZE THE TEMPERATURE INCREASE. CAUTION 4.1: 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 4.2: INSUFFICIENT IRRIGATION AND HIGH TIP PRESSURE (LOADING) UNDER EXTENDED EXPOSURE, E.G. IN TIGHT CAVITIES, ARE TO BE AVOIDED IN BONESCALPEL HARD TISSUE REMOVAL. IT IS RECOMMENDED TO WITHDRAW AND RE-INSERT THE ULTRASONIC TIP REPEATEDLY TO RE-ESTABLISH ADEQUATE COOLING AND LUBRICATION. CAUTION 4.3: ADDITIONAL EXTERNAL IRRIGATION, E.G. BY ADMINISTERING STERILE SALINE WITH A SYRINGE OVER THE DISTAL TIP PORTION, MAY BE NECESSARY FOR REMOVAL OF VERY DENSE, HARD OSSEOUS STRUCTURES OF THE SKULL, WHEN USING THE BONESCALPEL ACCESSORIES. CONCLUSION: THERE ARE ADEQUATE WARNINGS IN THE INSTRUCTION FOR USE MANUAL REGARDING CONDITIONS OF USE THAT MAY CAUSE OR CONTRIBUTE TO TISSUE NECROSIS. THE BURN DID NOT CAUSE PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE. THERE WAS NO REPORTED MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE. THERE WAS NO REPORTED DELAY IN TREATMENT. NO FURTHER ACTION IS TO BE TAKEN.

    Description of Event or Problem · 1

    CUSTOMER STATED PROBLEM AS "THE DISPOSABLE HEATED UP TO THE POINT OF CREATING A THERMAL BURN THROUGH THE BLACK CONE ON OPEN TISSUE DURING THE CASE. THE TISSUE WAS AN ASHY BLACK COLOR AFTERWARD. THE BLACK NOSE CONE DIDN'T SHOW SIGNED OF MELTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995178 BONESCALPEL-MICRO HOOK, LONG CURVED RIGID SHAVER ULTRASONIC SURGICAL SYSTEM LFL MISONIX INC MXB-MIS-S1 1317661 00841626101999

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention