BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS® BSA MICRO HOOK SHAVER AND TUBESET

    MDR report key: 18323467 · Received December 13, 2023

    Report

    Report Number
    2435119-2023-00022
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    November 10, 2023
    Report Date
    December 13, 2023
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K212060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 13, 2023, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON (B)(6) 2023, WHILE USING A NEXUS® BSA MICRO HOOK SHAVER AND TUBESET (PART NUMBER: 150-32-2210, LOT NUMBER: 233184) DURING AN ACDF C4-6 SURGICAL PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT HAD DECREASED MOTORS ON THE DELTOIDS AND BICEPS. MEDICAL INTERVENTION WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. A MALFUNCTION WAS NOT REPORTED. THE MISONIX REPRESENTATIVE PRESENT FOR THE CASE WAS MADE AWARE THAT THE PATIENT MOTORS HAD DECREASED; THEREFORE, THE PATIENT WASN'T ABLE TO LIFT THEIR ARMS AND SHOULDERS. THERE WAS NO STRUCTURAL DAMAGE TO THE PATIENT. THE SURGEON SAID THAT WHEN HE WAS IN THE FRAME AND DECOMPRESSING IS WHEN THE MOTOR CHANGES OCCURRED. ADDITION INFORMATION WAS RECEIVED ON NOVEMBER 21, 2023. IT WAS CONFIRMED SURGICAL TECHNIQUE WAS CONSISTENT PER THE INSTRUCTIONS FOR USE MANUAL. THE SURGEON HAS DONE OTHER ACDF CASES AND CERVICAL DISK REPLACEMENT CASES WITH THE BSA PROBE AND DID NOT HAVE ANY ISSUES. FOLLOW UP ON THE PATIENT'S CONDITION WITH THE SURGEON INDICATED ONE SIDE OF THE PATIENT HAD RECOVERED TO BASELINE BY THAT EVENING. THE DEVICE HISTORY RECORD FOR THE NEXUS® BSA MICRO HOOK AND SHAVER TUBESET (PART NUMBER: 150-32-2210) WAS REVIEWED. LOT NUMBER 233184 WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. INSPECTION AND TEST RESULTS MET SPECIFICATIONS. THERE WERE NO DEVIATIONS OR EXCEPTIONS NOTED. THE SUBJECT DISPOSABLE WAS RETURNED FOR EVALUATION. BASED ON OBSERVATIONS AND TESTING PERFORMED NO MANUFACTURING DEFECTS OR ABNORMAL BEHAVIOR WERE NOTED. THE CURRENT FREQUENCY OF OCCURRENCE IS WITHIN THE FREQUENCY ORIGINALLY ESTIMATED IN THE ORIGINAL RISK MANAGEMENT REPORT. THEREFORE, THERE IS NO CHANGE TO THE RESIDUAL RISK OR RISK-BENEFIT RATIO. THE INVESTIGATION HAS BEEN CONCLUDED. THE INSTRUCTIONS FOR USE MANUAL (100-10-1000, REVISION J) (IFU) FOR THE NEXUS® ULTRASONIC SURGICAL ASPIRATION SYSTEM CONTAINS THE FOLLOWING WARNING AND CAUTION: WARNING THE NEXUS® ULTRASONIC SURGICAL ASPIRATOR 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. 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.

    Description of Event or Problem · 0

    ON NOVEMBER 13, 2023, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A PRODUCT OCCURRENCE REPORT FOR AN EVENT THAT OCCURRED ON (B)(6) 2023, WHILE USING A NEXUS® BSA MICRO HOOK SHAVER AND TUBESET (PART NUMBER: 150-32-2210, LOT NUMBER: 233184) DURING AN ACDF C4-6 SURGICAL PROCEDURE. SPECIFICALLY, IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT HAD DECREASED MOTORS ON THE DELTOIDS AND BICEPS. MEDICAL INTERVENTION WAS NOT REPORTED. DELAY IN TREATMENT WAS NOT REPORTED. A MALFUNCTION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267015 NEXUS® BSA MICRO HOOK SHAVER AND TUBESET MIS MICRO HOOK SHAVER AND TUBESET LFL MISONIX, INC. 150-32-2210 233184

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other