BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XOM UNKNOWN ENDO (BUR)

    MDR report key: 4017854 · Received August 18, 2014

    Report

    Report Number
    1045254-2014-00192
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 28, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: MICRODEBRIDER 1898200T IGS M4 , SERIAL # (B)(4), LOT# 205760820, 510K: K041413, PRODUCT CODE: ERL, MANUFACTURED DATE MARCH 7, 2012. (B)(4). THE PRODUCT ANALYSIS FOR THE BUR STATED, ¿RECEIVED 1 SAMPLE, HIGH SPEED INNER BLADE FRAGMENT, PART NUMBER AND LOT NUMBER UNKNOWN. THERE WAS NO EVIDENCE OF BIOLOGICAL CONTAMINANTS. WHEN VIEWED UNDER MAGNIFICATION, THE INNER SHAFT HAD EXTENSIVE DAMAGE, ¿NUMEROUS INDENTATIONS, EXTENSIVE SCRAPES, AND THE BROKEN END WAS SMASHED SHUT¿. THE SHAFT MEASURED APPROXIMATELY 0.48 INCHES IN LENGTH. THE BREAK POINT EDGE WAS JAGGED. THE FLANGES OF THE BLUE HUB WERE FLARED AND THE TIPS WERE FLATTENED INDICATING IMPROPER LOADING. THE EDGE OF THE INNER HUB WAS FLARED WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. THERE WAS MELTING AROUND THE CIRCUMFERENCE OF THE HUB EDGE AND AN OBLONG MELT MARK APPROXIMATELY 0.15 INCHES IN LENGTH BELOW THE HUBS EDGE. NOTE: THE EXTENSIVE DAMAGE OBSERVED TO THE SHAFT WAS MOST LIKELY DUE TO HANDLING WHILE REMOVING THE HUB AND SHAFT FRAGMENT FROM THE HANDPIECE.¿ THE PRODUCT ANALYSIS FOR THE HANDPIECE (CONCOMITANT DEVICE) STATED, ¿A BLADE WAS STUCK IN THE HANDPIECE ON RECEIPT. REMOVED THE BROKEN BUR AND REPLACED NEW BEARINGS AND SEAL. [THE BEARINGS WERE CORRODED.] THE UNIT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS.¿ (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, ¿BLADE STUCK IN HANDPIECE, CANNOT BE PULLED OUT. CASE ALREADY FINISHED. NO PATIENT IMPACT.¿ ANALYSIS FOUND HEAT DAMAGE ON THE REMAINS OF THE BUR THAT WAS PARTIALLY PULLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495979 XOM UNKNOWN ENDO (BUR) EQJ MEDTRONIC XOMED INC. XOM UNKNOWN ENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H.10.