BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICUT® STRAIGHT SHAFT 4MM 11CM LONG

    MDR report key: 22033203 · Received May 16, 2025

    Report

    Report Number
    1045254-2025-01348
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    October 10, 2024
    Report Date
    May 16, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: VISUALLY, THE POUCH WAS OPEN FROM 3 OF 4 SIDES WHEN RETURNED. THERE WERE TRACES OF CONTAMINATION OBSERVED AT THE DISTAL END OF THE OUTER TUBE AND ON THE ENVELOPE. WHEN RETURNED, THE STYLLETE WAS INSIDE THE INNER ASSEMBLY, AND THE GAP BETWEEN INNER AND OUTER HUB WAS UNEVEN (ONE SIDE OF THE GAP WAS SMALLER THAN THE OTHER SIDE OF THE GAP). FUNCTIONALLY, THE INNER ASSEMBLY SPUN BY HAND WITH BINDING SOUND, AND THE INNER AND OUTER ASSEMBLIES WERE NOT STUCK TOGETHER WHEN RETURNED. THE DEVICE WAS LOADED INTO A HANDPIECE AND WHILE OSCILLATING UP TO 7 ,500RPM, THE DEVICE RESULTED IN EXCESSIVE WOBBLING. 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. THERE WAS ALSO DEEP STRIATION OBSERVED AT THE DISTAL END/TIP OF THE SHAFT. FURTHERMORE, THE OUTSIDE DIAMETER OF THE TIP SHALL MEASURE .1330+.000/-.0010 AND MEASURED .1326 WHICH WAS IN SPECIFICATION. THE DEVICE FAILED FUNCTIONAL TESTING DUE TO DEFECTIVE CONDITION UPON RETURN AND THE INABILITY TO SPIN PROPERLY. IN THE RETURNED CONDITION, THERE WAS NO OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT BUT THERE WERE OTHER FINDINGS OBSERVED DURING THE ANALYSIS OF THE RETURNED DEVICE. 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, AT THE INTRA OPERATIVE, WHEN CONNECTING THE BLADE, THE STRAIGHT BLADE WAS THAT THE INNER AND OUTER BLADES WERE STUCK TOGETHER, WHICH MADE IT IMPOSSIBLE TO ROTATE WHEN THE BLADE WAS CONNECTED AND THE FOOT PEDAL WAS PRESSED, AND IT DID NOT AFFECT THE SURGERY. THE PROBLEM WAS SOLVED BY REPLACING THE BLADE. THE BLADE WAS WOBBLING DURING ANALYSIS. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683783 TRICUT® STRAIGHT SHAFT 4MM 11CM LONG BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884004 0227539653 00763000543846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown