BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD® ROTATABLE BLADE

    MDR report key: 4189493 · Received October 21, 2014

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    Report

    Report Number
    3004209178-2014-20088
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES WERE NOT RETURNED. THEREFORE, AN ANALYSIS CANNOT BE PERFORMED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    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 TWO BLADES BROKE DURING AN FESS CASE. THE CURVED PORTION OF THE BLADE POPPED AND BROKE. FOLLOW-UP WITH THE CUSTOMER INDICATES THAT THE TIP BROKE OFF OF THE BURS AND THEY WERE ABLE TO RETRIEVE THE TIPS AS THEY BROKE OFF. THERE WAS A SLIGHT DELAY IN THE CASE WHILE REPLACEMENT BLADES WERE ATTACHED. HOWEVER, BOTH CASES WERE COMPLETED AND THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668571 RAD® ROTATABLE BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC PUERTO RICO OPERATIONS CO. 1884016HR HG01YBT

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR