BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR

    MDR report key: 6852272 · Received September 8, 2017

    Report

    Report Number
    1045254-2017-00314
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    August 15, 2017
    Report Date
    August 16, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    20721902100561
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: 1883672HS (BUR, 3PK HI SPEED DIAMOND 70DEG): LOT NUMBER - H8906338; MANUFACTURE DATE ¿ AUGUST 7, 2013; USE BY DATE ¿ AUGUST 7, 2021; UDI - (B)(4); (B)(4) (MICRODEBRIDER, M5): SERIAL NUMBER ¿ UNKNOWN; LOT NUMBER ¿ UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN; UDI ¿ UNKNOWN; 510K ¿ K081277. THE BURS AND HANDPIECE HAVE NOT BEEN RETURNED. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. 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 · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING A FRONTAL DRILL OUT, FIVE HIGH-SPEED BURS BROKE. ONE OF THE BURS WAS STUCK IN THE M5 HANDPIECE. ADDITIONAL INFORMATION FROM THE SALES REP INDICATES THAT THE BURS WERE 12K BURS, NOT 30K BURS. THE CUSTOMER MAY HAVE BEEN RUNNING 12K BURS AT 30K RPM. THERE WAS NO PATIENT INJURY OR IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632753 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1883672HS 0209277563 20721902100561

    Patients

    Seq Age Sex Outcome Treatment
    1