BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - IPC® M5 AND M4 30K

    MDR report key: 14205292 · Received April 26, 2022

    Report

    Report Number
    1045254-2022-00213
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    March 29, 2022
    Report Date
    June 14, 2022
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE INNER SHAFT OF THE BUR SEEMED TO BREAK AND COME LOOSE. BUR HUB WAS DESTABILIZED AND COULD BE PULLED APART. BUR WAS NOT MOVING CORRECTLY AT TIP - JUMPING AND SPARING IRRIGATION IRREGULARLY. EVENT OCCURRED DURING A REVISION FULL HOUSE FESS, LOTHROP PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    ON FOLLOW-UP, IT WAS REPORTED THAT THERE WERE NO FRAGMENTS THAT CAME OFF OR GOT DETACHED FROM THE BROKEN DEVICE. IT SEEMED TO BE THE INTERNAL SHAFT THAT WAS DAMAGED. BUR WAS MOVING AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590808 XPS® BUR - IPC® M5 AND M4 30K BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1883070BLD 0222754240

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male