BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONESCALPEL®, 10MM, BLUNT BLADE

    MDR report key: 15352597 · Received September 2, 2022

    Report

    Report Number
    2435119-2022-00007
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    March 26, 2022
    Report Date
    September 2, 2022
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K070313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON AUGUST 04, 2022, MISONIX RECEIVED A PRODUCT OCCURRENCE REPORT ON A BONESCALPEL®, 10MM, BLUNT BLADE (PART NUMBER MXB-10, LOT NUMBER 213297) THAT OCCURRED ON (B)(6) 2022, DURING A PROCEDURE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. MEDICAL INTERVENTION, CT SCAN, WAS REPORTED. IT WAS REPORTED THAT "THE BONE SCALPEL BLADE BURNT SOME BONE IN THE ORBIT AND A PIECE OF THE METAL TIP BROKE OFF AND BECAME LODGED IN THE BONE. NEW TIP USED. THE METAL PIECE WAS REMOVED, NO APPARENT HARM WAS DONE AND A CT CONFIRMED NO METAL WAS LEFT IN THE BONE." THE REPORTER CONFIRMED THERE WERE NO ADVERSE REACTIONS REPORTED AFTER THE PROCEDURE. FOLLOW UP CONFIRMED THERE WAS NO UNDERLYING INJURY TO THE PATIENT. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE BONESCALPEL®, 10MM, BLUNT BLADE (PART NUMBER MXB-10, LOT NUMBER 213297). LOT #213297 WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. INSPECTION AND TEST RESULTS MET SPECIFICATIONS. THERE WERE NO DEVIATIONS OR EXCEPTIONS NOTED. A REVIEW OF ALL AVAILABLE POST-MARKET SURVEILLANCE INFORMATION INVOLVING THIS PRODUCT AND LOT NUMBER DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS. THE CURRENT FREQUENCY OF OCCURRENCE IS WITHIN THE FREQUENCY IN THE ORIGINAL RISK MANAGEMENT REPORT. THERE IS NO CHANGE TO THE RESIDUAL RISK OR RISK-BENEFIT RATIO. THE BONESCALPEL® IFU (BCM-UM, REVISION U) CONTAINS INCLUDES WARNINGS AND CAUTIONS REGARDING THE SURGICAL TECHNIQUE AND DEVICE SETTINGS REQUIRED TO PREVENT THERMAL INJURY, TISSUE NECROSIS, AND BURNS TO PATIENT TISSUE. 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 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 7.2: DO NOT OPERATE PUMP WITH PUMP COVER IN RAISED POSITION. ROLLERS MIGHT PINCH LOOSE CLOTHING OR FINGERS. PERSONAL INJURIES MAY RESULT. COOLING OF THE ULTRASONIC TIP AND IRRIGATION AT THE TREATMENT SITE WILL BE INHIBITED. 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 4.2: 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. THE INVESTIGATION HAS BEEN CONCLUDED. CUSTOMER REPORTED THAT THE SUBJECT DEVICE IS NOT AVAILABLE FOR RETURN TO MISONIX FOR EVALUATION; THEREFORE, A THOROUGH INVESTIGATION COULD NOT BE CONDUCTED.

    Description of Event or Problem · 0

    ON AUGUST 04, 2022, MISONIX RECEIVED A PRODUCT OCCURRENCE REPORT ON A BONESCALPEL®, 10MM, BLUNT BLADE (PART NUMBER MXB-10, LOT NUMBER 213297) THAT OCCURRED ON (B)(6) 2022, DURING A PROCEDURE. A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. MEDICAL INTERVENTION, CT SCAN, WAS REPORTED. IT WAS REPORTED THAT "THE BONE SCALPEL BLADE BURNT SOME BONE IN THE ORBIT AND A PIECE OF THE METAL TIP BROKE OFF AND BECAME LODGED IN THE BONE. NEW TIP USED. THE METAL PIECE WAS REMOVED, NO APPARENT HARM WAS DONE AND A CT CONFIRMED NO METAL WAS LEFT IN THE BONE." THE REPORTER CONFIRMED THERE WERE NO ADVERSE REACTIONS REPORTED AFTER THE PROCEDURE. FOLLOW UP CONFIRMED THERE WAS NO UNDERLYING INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368822 BONESCALPEL®, 10MM, BLUNT BLADE ULTRASONIC SURGICAL SYSTEM DISPOSABLE LFL MISONIX, INC. MXB-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R