BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR

    MDR report key: 4974295 · Received August 5, 2015

    Report

    Report Number
    1045254-2015-00265
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 15, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS, BUT IS EXPECTED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PRODUCT ANALYSIS, THE INNER SHAFTS BROKE 0.62¿ FROM THE DISTAL FACE OF THE INNER HUB WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. THE BREAK POINTS CORRESPOND TO THE PROXIMAL END OF THE OUTER TUBE IN THE FRONT HUB. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS DEFORMATION OF THE LOCKING AREAS ON THE FRONT HUBS AND STRIATIONS AROUND THE OUTSIDE DIAMETERS OF THE SHAFTS INDICATING METAL ON METAL CONTACT. THE INFORMATION INDICATES EXCESS PRESSURE WAS APPLIED DURING USE WHICH CAUSED THE DEFORMATION OF THE LOCKING AREA; WHICH THEN CAUSED THE INNER SHAFTS AND OUTER TUBES TO RUB TOGETHER UNTIL THE INNER SHAFT BROKE. THERE WAS NO INDICATION OF DEVICE FRAGMENTS AND THE BREAKAGE WOULD HAVE BEEN CONTAINED BY THE OUTER TUBE AND THE HANDPIECE. NOTE: THE OBSERVED DAMAGE HAS PREVIOUSLY BEEN REPRODUCED BY USING EXCESS FORCE DURING USE WITH A RESERVE SAMPLE BLADE. METHOD: ACTUAL DEVICE EVALUATED, MICROSCOPIC INSPECTION, VISUAL INSPECTION, LABELING EVALUATION. RESULTS: STRESS PROBLEM. CONCLUSION: USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    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 THE HIGH SPEED BUR BROKE DURING THE CASE. IT WAS CHANGED OUT FOR ANOTHER, WHICH ALSO BROKE. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. "THE INITIAL USE OF THE DEVICE WAS DURING A PITUITARY GLAND PROCEDURE AND THE BROKEN PART WAS THE SPIRAL WRAP. IN FACT WHEN THEY DID THIS KIND OF PROCEDURE, THEY FORCED ON THE BURR TO BE MORE EFFECTIVE BUT SOMETIMES IT WAS TO IMPORTANT AND THE BUR BROKE. NO BROKEN PART INSIDE THE PATIENT, NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518822 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884560HS 0209572878

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR