BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER BLADES AND BURS

    MDR report key: 14492246 · Received May 24, 2022

    Report

    Report Number
    1045254-2022-00269
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    February 24, 2022
    Report Date
    May 25, 2022
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: VISUALLY, THE INNER SHAFT AND HUB BUSHING WERE DISLODGED AND MISSING FROM THE INNER HUB. THE INNER HUB SEAL WAS STILL IN PLACE BUT WAS WORN. THERE WAS DEFORMATION IN THE DISTAL OUTSIDE DIAMETER OF THE INNER HUB WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE OUTSIDE DIAMETER OF THE INNER HUB SHOULD BE 0.330 ± 0.002 INCHES AND MEASURED 0.329 INCHES IN THE UNDAMAGED AREA AND MEASURED UP 0.351 INCHES IN THE DEFORMED AREA WHICH WAS OUT OF SPECIFICATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BROKEN STATE OF THE DEVICE. CONCLUSION: IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT (DUE TO PHYSICAL DAMAGE). 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 DISPOSABLE PIECE WAS BROKEN INSIDE THE HP. EVENT FOUND POST-OP. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE BUR BROKE INTO FRAGMENTS. THE MIDDLE PART OF THE BUR BROKE AND THE BROKEN PARTS WERE NOT CONTAINED IN THE HANDPIECE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. A BACK-UP DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194634 MICRODEBRIDER BLADES AND BURS BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNK MICDEBBUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown