BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX MR8

    MDR report key: 24599531 · Received March 13, 2026

    Report

    Report Number
    1625507-2026-00149
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    January 17, 2026
    Report Date
    May 14, 2026
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    UDI-DI
    00763000441005
    PMA / PMN Number
    K183515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: EVALUATION COULD NOT REPRODUCE THE REPORTED MALFUNCTION OF DEVICE NOT WORKING. HOWEVER, IT WAS NOTED THAT NORMAL DUST, DAMAGE TO THE INTERNAL BEARINGS, GENERATING HIGH TEMPERATURES DURING ACTIVATION WITH POSSIBLE CAUSES INCLUDING IMPACTS, MISUSE, OR LEVERAGE DURING ACTIVATION. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: PSS UNKNOWN MOTOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: MR8-F2/7TA23, SERIAL/LOT #: (B)(6): UBD: 19-SEP-2030, UDI#: (B)(4). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: ANALYSIS WAS NOT PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED AFTER MULTIPLE ATTEMPTS. DEVICE RETURN IS NOT EXPECTED DUE TO RETURN LOGISTICAL LIMITATIONS. NO RETURN INFORMATION IS AVAILABLE AT THIS TIME. SO CURRENT POSSESSION STATUS IS UNVERIFIED. INDICATIONS FOR USE INSTRUCTS THE CUSTOMER THAT PRODUCTS SHOULD BE RETURNED FOR REGULAR SERVICING. ONCE THE PRODUCT HAS BEEN RETURNED, THE COMPLAINT WILL BE RE-OPENED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING A TUMOR SUPRATENTORIAL PROCEDURE, THE BUR WAS INSTALLED AND FUNCTIONED NORMALLY. WHEN THE BLADE ATTACHMENTS WERE EXCHANGED, THE BLADE WAS CONNECTED. UPON PRESSING THE PEDAL, THE BLADE DID NOT ACTIVATE AND THERE WAS NO SOUND OR MOVEMENT. FOLLOWING DR. (B)(6) INSTRUCTION, THE MOTOR WAS REPLACED WITH THE INSTITUTION¿S MIDAS MOTOR, WHICH OPERATED CORRECTLY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING BACKUP PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING A TUMOR SUPRATENTORIAL PROCEDURE, THE BUR WAS INSTALLED AND FUNCTIONED NORMALLY. WHEN THE BLADE ATTACHMENTS WERE EXCHANGED, THE BLADE WAS CONNECTED. UPON PRESSING THE PEDAL, THE BLADE DID NOT ACTIVATE AND THERE WAS NO SOUND OR MOVEMENT. FOLLOWING DR. FEO¿S INSTRUCTION, THE MOTOR WAS REPLACED WITH THE INSTITUTION¿S MIDAS MOTOR, WHICH OPERATED CORRECTLY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING BACKUP PRODUCTS. ADDITIONAL INFORMATION RECEIVED STATING THAT THE INTERNAL BEARING WAS DAMAGED WERE FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269758 MIDAS REX MR8 DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS MR8-AF02 00763000441005

    Patients

    Seq Age Sex Outcome Treatment
    1