BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - UNKNOWN

    MDR report key: 6647113 · Received June 16, 2017

    Report

    Report Number
    1045254-2017-00194
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Report Date
    May 18, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 1899200RF: M5 MICRODEBRIDER REFURB, SERIAL # (B)(4), LOT # 209448826, MANUFACTURED DATE ¿ APR/3/2015, 510(K) # K081277, UDI # (B)(4). THE BUR AND M5 HANDPIECE WERE RETURNED FOR EVALUATION. EVALUATION OF THE BUR INDICATED THAT THE RETURNED SAMPLES SHOWED THAT THE INNER SHAFT WAS CUT NEAR THE INNER HUB. THE CUT IS TYPICALLY PERFORMED TO REMOVE THE BUR FROM THE HANDPIECE. THE TIP AS REFERRED TO BY THE CUSTOMER IS MOST LIKELY THE ¿PROXIMAL END¿ TIP INSIDE THE HANDPIECE AND NOT THE ¿DISTAL END TIP.¿ THE STATEMENT ¿TIP BROKE OFF IN HANDPIECE¿ ALSO SUPPORTS THE LOCATION OF THE BREAK SINCE THE PROXIMAL END OF THE BUR IS WHAT IS LOADED IN THE HANDPIECE. VISUALLY, THE DISTAL END OF THE INNER HUB OUTSIDE DIAMETER WAS DEFORMED. THE HUB OUTSIDE DIAMETER REQUIREMENT IS 0.330¿ / +-0.005¿ AND MEASURED 0.328¿ IN THE UNDAMAGED AREA AND 0.354¿ IN THE DEFORMED AREA WHICH WOULD LIKELY CAUSE THE BLADE TO GET STUCK IN THE HANDPIECE. THERE WAS NO ALLEGATION OF DIFFICULTIES LOADING THE BUR. THE INNER SHAFT WAS CRUSHED WITH TOOL MARKS PRESENT, AND CUT OFF, WHICH LIKELY OCCURRED WHEN IT WAS FORCIBLY REMOVED FROM THE HANDPIECE. THE INFORMATION IS CONSISTENT WITH HEAT INDUCED DEFORMATION BROUGHT ON BY EXCESS FRICTION BETWEEN THE INNER AND FRONT HUBS. NOTE: THE M5 HANDPIECE USED HAS A TOP SPEED OF 30,000 RPM; THIS PRODUCT FAMILY TYPICALLY HAS A MAXIMUM RECOMMENDED SPEED OF 12,000 RPM. THE IFU WARNS, DO NOT USE BURS ABOVE THE SPEED INDICATED ON THE BUR LABEL; AND EXCESSIVE PRESSURE APPLIED TO BUR / BLADE MAY CAUSE DAMAGE. EVALUATION OF THE M5 HANDPIECE INDICATED THAT THE DEVICE AS STALLING AND THE TIP OF THE BUR WAS FOUND BROKEN INSIDE. THERE WAS FOREIGN MATERIAL BUILT UP IN THE REAR BEARINGS. THE TIP AND THE FOREIGN MATERIAL WAS REMOVED FROM THE HANDPIECE. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. 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 FACILITY REPORTED THAT THE TIP OF THE BUR/BLADE BROKE OFF IN THE HANDPIECE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427607 XPS® BUR - UNKNOWN BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNKNOWN BUR

    Patients

    Seq Age Sex Outcome Treatment
    1