BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® HANDPIECE - UNKNOWN

    MDR report key: 6087317 · Received November 8, 2016

    Report

    Report Number
    1045254-2016-00386
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT NUMBER - TN45RCD; DESCRIPTION - TRANSNASAL BUR, 4.5MM RND CRS DMD; LOT NUMBER - 0210979241; MANUFACTURE DATE - MARCH 15, 2016; USE BEFORE DATE - SEPTEMBER 6, 2017; 510K - K081277. XOM UNKNOWN DRILL (HANDPIECE/DRILL): THE CUSTOMER BELIEVED THERE WAS NO FAULT WITH THE HANDPIECE AS THE OVERHEATING ISSUE WAS RESOLVED BY REPLACING THE BUR. THEREFORE, THE CUSTOMER WILL NOT BE RETURNING THE HANDPIECE FOR ANALYSIS. THE PRODUCT NUMBER AND SERIAL NUMBER WAS NOT PROVIDED. TN45RCD (TRANSNASAL BUR): ONE UN-SEALED SAMPLE OF TN45RCD FROM LOT NUMBER 0210979241 WAS RECEIVED. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS BASED OFF THE REACTIVITY WITH HYDROGEN PEROXIDE. THE EQUIPMENT USED INCLUDES A MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0, 65 TO 5, 0 MAGNIFICATION SETTINGS), IPC CONSOLE IN CONJUNCTION WITH A LEGEND STYLUS HANDPIECE, AND AN IR THERMOMETER. WHEN COMPARED TO THE ASSEMBLY DRAWING, THE INNER ASSEMBLY SPUN FREELY BY HAND. THERE WAS NO EXTERNAL DAMAGE TO THE DEVICE. HOWEVER, THERE WAS BIOLOGICAL CONTAMINANTS COMPACTED IN THE DIAMOND GRIT TIP, WHICH MAY LEAD TO EXCESS PRESSURE TO MAINTAIN PERFORMANCE. THE BUR WAS TESTED FOR ONE MINUTE AT 60,000 RPM WITH NO IRRIGATION. THE MOTOR HOUSING AND BUR MEASURED APPROXIMATELY 74 DEGREES FAHRENHEIT PRIOR TO TESTING. AFTER TESTING, THEY BOTH MEASURED APPROXIMATELY 76 DEGREES FAHRENHEIT. THERE WAS NO OVERHEATING OBSERVED. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING AND THEREFORE HAS BEEN RULED OUT AS A LIKELY CAUSE. THE COMPLAINT WAS NOT CONFIRMED FOR THE ALLEGED MALFUNCTION (OVERHEATING).

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) #: (B)(4). 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5-10 SECONDS AFTER STARTING TO WORK, THE BUR AND HANDPIECE OVERHEATED. THE BUR WAS REPLACED AND THE OVERHEATING ISSUE WAS RESOLVED. THE SAME HANDPIECE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738113 XPS® HANDPIECE - UNKNOWN DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. XOM UNKNOWN DRILL

    Patients

    Seq Age Sex Outcome Treatment
    1