BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATED CANNULATED 4.5MM TAP

    MDR report key: 24888631 · Received April 15, 2026

    Report

    Report Number
    1723170-2026-00608
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    February 19, 2026
    Report Date
    April 15, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: ANALYSIS WAS PERFORMED FOR PRODUCT: 9734298, LOT NUMBER: 140814. IT WAS REPORTED THAT THE RETURNED TAP WAS SLIGHTLY DEFORMED AT THE TIP IN AN OUT OF ROUND CONDITION. THE TAP WAS IN OTHERWISE GOOD CONDITION. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT PRIOR TO A CASE, THE GUIDE WIRE WOULD NOT PASS THROUGH THE CANNULATED TAP. IT WAS NOTICED THAT THE PROXIMAL END OF THE TAP WAS DEFORMED, CAUSING THE GUIDEWIRE TO NOT GO SMOOTHLY THROUGH THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. THE ACTIONS TAKEN TO RESOLVE THIS ISSUE WAS THAT THEY USED A DIFFERENT INSTRUMENT TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554990 NAVIGATED CANNULATED 4.5MM TAP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 9734298 140814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown