BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    70 DEG CURVED SUCTION, AXIEM

    MDR report key: 22039277 · Received May 16, 2025

    Report

    Report Number
    1723170-2025-01992
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    March 17, 2025
    Report Date
    June 5, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS WAS PERFORMED FOR PRODUCT: (B)(4) , LOT NUMBER: 230718. IT WAS REPORTED THAT THE RETURNED CURVED SUCTION WAS UNABLE TO VERIFY WHEN CONNECTED TO A KNOWN GOOD SYSTEM. THE CURVED SUCTION DISPLAYED DIVOT ERRORS OF 2.4MM TO 2.5MM. CODES B01, C07 AND D02 ARE APPLICABLE TO THIS ANALYSIS. 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

    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

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT UPON INSPECTION, A VERIFICATION DEFECT WAS DETECTED IN BOTH THE TWO 70 DEGREE SUCTION INSTRUMENTS AND THE TWO STRAIGHT SUCTION INSTRUMENTS, WHICH WERE ONLY BARELY ACCEPTABLE FOR DISTANCE TO DIVOT, AND TIP DEFORMATION WAS SUSPECTED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. VERIFICATION DID NOT COMPLETE, IT WAS TRIED SEVERAL TIMES, BUT IT WAS NOT POSSIBLE. IT WAS VERIFIED AND A SIMILAR PHENOMENON WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142639 70 DEG CURVED SUCTION, AXIEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733450 190422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown