BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER BLADES AND BURS

    MDR report key: 14470910 · Received May 23, 2022

    Report

    Report Number
    1045254-2022-00262
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    November 10, 2021
    Report Date
    May 23, 2022
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: VISUALLY, THE INNER SHAFT WAS DISPLACED AND MISSING FROM THE INNER HUB WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THERE WAS DEFORMATION IN THE DISTAL OUTSIDE DIAMETER OF THE INNER HUB. THE OUTSIDE DIAMETER OF THE INNER HUB SHOULD BE 0.330 ± 0.002 INCHES AND MEASURED 0.329 INCHES IN THE UNDAMAGED AREA AND UP TO 0.353 INCHES IN THE DEFORMED AREA WHICH WAS OUT OF SPECIFICATION. THE HUB WASHER WAS DISLODGED FROM THE DISTAL END OF THE HUB. 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

    HEALTH CARE PROFESSIONAL REPORTED THAT DURING USE THE DEVICE HANDLE BROKEN AND FOREIGN OBJECT INSIDE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551793 MICRODEBRIDER BLADES AND BURS BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNK MICDEBBUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown