BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING

    MDR report key: 19199810 · Received April 29, 2024

    Report

    Report Number
    1045254-2024-00624
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 29, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    00763000579241
    PMA / PMN Number
    K130608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS FOUND THAT VISUALLY, THE INNER SHAFT WAS BENT DISTAL TO THE INNER HUB WHEN RETURNED. THERE WERE INDENTIONS ON THE OUTSIDE DIAMETER OF THE ROTATING HUB AND CONTAMINATION ON THE OUTSIDE DIAMETER OF THE INNER SHAFT. ADDITIONALLY, THERE WERE STRIATIONS ON THE OUTSIDE DIAMETER OF THE SHAFT 0.57 INCHES FROM THE DISTAL END OF THE INNER HUB. FUNCTIONALLY, THE INNER AND MIDDLE ASSEMBLIES SPUN FREELY BY HAND WITH NO BINDING. THE BLADE FIT SECURELY INTO A HANDPIECE, BUT WHILE OSCILLATING AT 7500RPM, EXCESSIVE WOBBLING WAS OBSERVED. A REVIEW OF THE GLOBAL COMPLAINT DATA SHOWED NO OTHER COMPLAINTS ABOUT THIS LOT NUMBER. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT (DUE TO PHYSICAL DAMAGE). 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 DURING INTRA-OP, THE TRICUT BLADE WAS WOBBLING. THERE WAS A SURGICAL DELAY OF 20 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THE PATIENT STATUS IS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED STATING THAT BLADE WAS NOT CHECKED PRIOR TO USE FOR WOBBLE. THE BLADE WOBBLED DURING INITIAL USE. FESS PROCEDURE WAS BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493440 TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884080EM 0227197990 00763000579241

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female