BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONESCALPEL® HANDPIECE

    MDR report key: 20848264 · Received December 4, 2024

    Report

    Report Number
    2435119-2024-00048
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    October 2, 2024
    Report Date
    December 4, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K070313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BONESCALPEL® HANDPIECE (P/N: BCM-HP, S/N: (B)(6). ON OCTOBER 03, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED CONFIRMATION OF AN EVENT INVOLVING THREE BONESCALPEL® HANDPIECES (P/N: BCM-HP, S/N: (B)(6) DURING A SURGICAL PROCEDURE ON (B)(6) 2024. SPECIFICALLY, THE REPORTER INDICATED "THE HANDPIECES HEAT UP ~5 MINUTES INTO USE" AND A "WET PACK IS USED TO COOL THEM DOWN". A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON (B)(6) 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA WHICH PROLONGED THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY IN TREATMENT. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE BONESCALPEL® HANDPIECE (P/N: BCM-HP, S/N: (B)(6) IN USE AT THE TIME OF THE EVENT. THERE WERE NO DEVIATIONS FOUND DURING IN-PROCESS OR FINAL INSPECTION OF THE HANDPIECE. INSPECTION AND TEST RESULTS MET SPECIFICATIONS PRIOR TO RELEASE TO COMMERCE. THE SUBJECT HANDPIECE WAS RETURNED TO MISONIX FOR EVALUATION. INSPECTION AND TESTING CONCLUDED THE HANDPIECE HAD WATER INTRUSION AND FAILED TRANSDUCER HI-POT TESTING. THE DEVICE WAS REPAIRED BY REPLACING THE HANDPIECE CABLE ASSEMBLY. ALL INSPECTION AND TEST RESULTS WERE IN CONFORMANCE WITH MISONIX'S SPECIFICATIONS AFTER THE REPAIR. A REVIEW OF ALL AVAILABLE POST MARKET SURVEILLANCE DATA HAS NOT SHOWN ADVERSE TRENDS RELATED TO THIS OR SIMILAR EVENTS. 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 INSTRUCTIONS FOR USE MANUAL (BCM-UM, REVISION W) (IFU) FOR THE BONESCALPEL® SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS: WARNING: 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: 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: 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. CAUTION: PRIME THE IRRIGATION TUBING PRIOR TO USE. AT ALL TIMES ENSURE THAT THE IRRIGANT FLOWS TOWARDS THE HANDPIECE WHEN FOOTSWITCH IS DEPRESSED. IF NO IRRIGANT IS FLOWING, CEASE USE UNTIL FLOW IS RESTORED. CAUTION: THE SYSTEM CHECK SHOULD ALWAYS BE DONE IN ADVANCE OF PREPARING PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. THIS INVESTIGATION HAS BEEN CONCLUDED.

    Description of Event or Problem · 0

    BONESCALPEL® HANDPIECE (P/N: BCM-HP, S/N: (B)(6)). ON OCTOBER 03, 2024, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED CONFIRMATION OF AN EVENT INVOLVING THREE BONESCALPEL® HANDPIECES (P/N: BCM-HP, S/N: (B)(6) DURING A SURGICAL PROCEDURE ON (B)(6) 2024. SPECIFICALLY, THE REPORTER INDICATED "THE HANDPIECES HEAT UP ~5 MINUTES INTO USE" AND A "WET PACK IS USED TO COOL THEM DOWN". A SERIOUS INJURY TO THE PATIENT OR USER WAS NOT REPORTED. MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS NOT REPORTED; HOWEVER, ON (B)(6) 2024, MISONIX RECEIVED CONFIRMATION OF A DELAY IN TREATMENT GREATER THAN 15 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA WHICH PROLONGED THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977668 BONESCALPEL® HANDPIECE HANDPIECE LFL MISONIX, INC. BCM-HP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other