BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XOM UNKNOWN DRILL

    MDR report key: 4035141 · Received August 25, 2014

    Report

    Report Number
    1045254-2014-00204
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). CONCOMITANT DEVICE: MICRODEBRIDER 1898200T IGS M4, 510K: K041413, SERIAL # (B)(4), LOT# 205729161, MANUFACTURE DATE: FEB. 21, 2012. THE PRODUCT ANALYSIS FOR THE RETURNED BUR FOUND THAT THE CONDITION OF THE DEVICE PREVENTED IDENTIFICATION OF THE PART AND/OR LOT NUMBER. IN ADDITION, HOW AND WHEN THE IDENTIFIABLE DAMAGE OCCURRED WAS NOT DISCERNIBLE. AS A RESULT AN ANALYSIS COULD NOT BE PERFORMED; THEREFORE, NO CONCLUSION(S) COULD BE DRAWN. ALTHOUGH THE EXACT PART NUMBER COULD NOT BE DETERMINED THE RETURNED PORTION SUGGESTED THAT THIS WAS A MEDTRONIC M4 HIGH SPEED STRAIGHT BUR. CHARACTERIZATION OF THE RETURNED PORTION SHOWED: THE PORTION RETURNED WAS THE INNER TUBE WITH THE INNER HUB ATTACHED. THE PORTION NOT RETURNED WAS THE VERY TIP OF THE INNER TUBE [WHICH WAS BROKE OFF] AND THE OUTER TUBE / HUB ASSEMBLY. THE FOLLOWING WAS THE OBSERVED DAMAGE; SHAFT/TUBE WAS BENT IN MULTIPLE AREAS, THE WASHER WAS MELTED TO THE INNER HUB [OFF CENTER], AND THE TIP WAS BROKE OFF AS INDICATED ABOVE. THE REPORTED ¿STUCK IN THE HANDPIECE¿ MAY HAVE BEEN THE RESULT OF THE WASHER BEING MELTED TO THE HUB OFF CENTER HOWEVER THIS CANNOT BE CONFIRMED. THE PRODUCT ANALYSIS FOR THE CONCOMITANT DEVICE FOUND THAT THE BUR WAS IN FACT STUCK IN THE HANDPIECE, AND THAT THE HANDPIECE¿S INTERNAL PARTS WERE CORRODED OVER TIME DUE TO EXPOSURE TO SALINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP, THE BUR BECAME STUCK IN THE HANDPIECE. THERE WAS NO PATIENT IMPACT. WHEN THE BUR WAS RETURNED, FRAGMENTS OF IT WERE MISSING AND MELTING OF COMPONENTS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511857 XOM UNKNOWN DRILL EQJ MEDTRONIC XOMED, INC XOM UNKNOWN DRILL

    Patients

    Seq Age Sex Outcome Treatment
    1