BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRODEBRIDER BLADES AND BURS

    MDR report key: 14039737 · Received April 7, 2022

    Report

    Report Number
    1045254-2022-00175
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    February 28, 2022
    Report Date
    April 7, 2022
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON TOLD SALES REPRESENTATIVE THAT DURING FESS BUR BROKE INSIDE OF THE PATIENT WHILE PERFORMING A DRILL OUT OF THE FRONTAL SINUS. THE BUR LOOKED AS THOUGH IT SHREDDED APART INSIDE OF THE MICRODEBRIDER SHAFT. THERE WAS INTERVENTION PERFORMED TO RETRIEVE THE BROKEN BUR PIECES. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS PROCEDURE DELAY OF 30 MINUTES AND PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). PATIENT WAS ALIVE AND NO INJURY. ON FOLLOW-UP IT WAS MENTIONED THAT DURING THE CONVERSATION WITH THE CUSTOMER IT WAS FOUND THAT THE CUSTOMER DIDN¿T REALIZE THAT SOME BURS WERE INTENDED TO GO 12K RPM AND SOME UP TO 30K, OR THAT SOME BURS WERE INTENDED FOR DIFFERENT KINDS OF HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342280 MICRODEBRIDER BLADES AND BURS BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNK MICDEBBUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention