BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 3533635 · Received December 23, 2013

    Report

    Report Number
    1045254-2013-00613
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Report Date
    November 11, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: CONCOMITANT DEVICE: 1898200T - MICRODEBRIDER, 1898200T IGS M4, S/N (B)(4), LOT 65197300, MANUFACTURED DECEMBER 8, 2009, RECEIVED ON (B)(4) 2013, 510K: K041413. (B)(4). PRODUCT EVALUATION: ANALYSIS DETERMINED THAT THE RETURNED PRODUCT APPEARED TO BE A HIGH SPEED BUR BUT THE EXACT PART NUMBER (CFN/UPN) COULD NOT BE DETERMINED. UPON VISUAL EVALUATION, ONLY THE INNER SHAFT WAS RETURNED. THE OUTER SHAFT ASSEMBLY WAS NOT RETURNED FOR EVALUATION. THE INNER SHAFT WAS FOUND BENT AND BROKEN APPROXIMATELY 1.7CM FROM THE EDGE OF THE HUB ASSEMBLY. THE SECOND BROKEN PIECE OF INNER SHAFT WAS FOLDED NEAR ITS BROKEN EDGE. THIS LIKELY OCCURRED WHEN SERVICE AND REPAIR ATTEMPTED TO REMOVE THE STUCK BUR PIECE FROM THE HANDPIECE. THE BROKEN BUR TIP AND THE REMAINING BROKEN SHAFT ASSEMBLY WAS NOT RETURNED FOR EVALUATION. THE BLUE HUB HAD ONE OF ITS RIDGES BROKEN WHICH INDICATED THAT THE BUR WAS NOT LIKELY SEATED / LOADED PROPERLY INSIDE THE HANDPIECE. THERE WERE ALSO OBVIOUS CIRCULAR BURNT MARKINGS NOTED ON THE BLUE HUB WHICH PROVIDED EVIDENCE THAT THE BUR WAS LIKELY MISLOADED INSIDE THE HANDPIECE WHICH CAUSED IT TO BE STUCK AND BREAK IN THE MANNER OBSERVED. ANALYSIS FOR THE M4 MICRODEBRIDER (B)(4) FOUND THE BLADE BROKEN INSIDE THE UNIT. THERE WAS AN M2 BLUE BLADE BROKEN INSIDE THE M4 HANDPIECE. REPLACED THE REAR BEARING AND SEAL DUE TO WEAR AND TEAR. UNIT WAS REPAIRED CLEANED AND TESTED TO MANUFACTURING SPECIFICATIONS. METHOD: MICROSCOPIC INSPECTION; RESULTS: FRACTURE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR IS STUCK IN THE HANDPIECE. WHEN RECEIVED IN SERVICE AND REPAIR IT WAS DISCOVERED THAT THE BUR WAS BROKEN AND THE HUB END WAS STUCK IN THE HANDPIECE. INITIAL OBSERVATIONS INDICATE THAT THE PRODUCT RECEIVED IS A HIGH SPEED BUR. IT WAS CONFIRMED THAT ¿THE M4 WAS USED AT A CADAVER LAB AND NO FURTHER INFORMATION IS AVAILABLE. THIS WAS NOT USED ON A ¿LIVING¿ PERSON, BUT ON A CADAVER.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672830 UNKNOWN BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1