BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICUT® STRAIGHT SHAFT 4MM 11CM LONG

    MDR report key: 22116253 · Received May 30, 2025

    Report

    Report Number
    1045254-2025-01437
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    November 16, 2024
    Report Date
    July 15, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    00763000543846
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOUND THAT VISUALLY, THE POUCH WAS OPEN FROM 3 OF 4 SIDES WHEN RETURNED. THERE WAS NO DAMAGE (EXTERNAL) NOTED TO THE TUBING SET OR THE BLADE. THERE WERE TRACES OF CONTAMINATION OBSERVED AT THE DISTAL END OF THE OUTER TUBE, AND AT THE PROXIMAL END OF THE INNER SHAFT. IT WAS ALSO OBSERVED THAT THE GAP BETWEEN THE INNER AND OUTER HUB WAS UNEVEN. FUNCTIONALLY, THE INNER ASSEMBLY SPUN BY HAND WITH BINDING SOUND, AND THE INNER AND OUTER BLADES WERE NOT FIXED TOGETHER. THE DEVICE WAS LOADED INTO A HANDPIECE AND WHILE OSCILLATING UP TO 7,500RPM, THE WOBBLING WAS OBSERVED. FOR FURTHER ANALYSIS, THE INNER ASSEMBLY WAS PULLED OUT OF THE OUTER ASSEMBLY, AND IT WAS NOTICED THAT THE INNER SHAFT WAS BENT NEAR THE DISTAL END OF THE INNER HUB. THE STRIATIONS WERE ALSO OBSERVED AT THE DISTAL END/TIP OF THE SHAFT AND NEAR THE DISTAL END OF THE INNER HUB. FURTHERMORE, THE INNER SHAFT TIP WAS MEASURED, AND THE OUTSIDE DIAMETER OF THE TIP SHALL MEASURE .1330+.000/-.0010 AND MEASURED .1328 WHICH WAS IN SPECIFICATION. DESPITE THE ALLEGED COMPLAINT, IT WAS OBSERVED THAT THE BLADE COULD TURN, AND THE INNER AND OUTER BLADES WERE NOT FIXED TOGETHER. 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

    D4: UDI HAS BEEN UPDATED. H6: ANNEX D/FDC CODE HAS BEEN UPDATED. 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 REPORTED THAT, DURING INTRA OPERATIVE, STRAIGHT BLADE WAS CONNECTED TO THE M5. WHEN THE PEDAL WAS PRESSED, THE BLADE DID NOT TURN. WHEN THE BLADE WAS UNPLUGGED, THE INNER AND OUTER BLADES WERE FIXED TOGETHER, MAKING IT IMPOSSIBLE TO ROTATE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9875 TRICUT® STRAIGHT SHAFT 4MM 11CM LONG BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884004 0227539654 00763000543846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown