BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFERIOR TURBINATE BLADE 2.9MM

    MDR report key: 3224785 · Received July 12, 2013

    Report

    Report Number
    1045254-2013-00456
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT HAS BEEN RETURNED, EVALUATION EXPECTED.

    Additional Manufacturer Narrative · 1

    DEVICE NAME: INFERIOR TURBINATE BLADE 2.9MM. PROCODE: EQJ. MODEL #1882940HR; LOT #H8672833; EXPIRATION DATE 03/14/2017. CONCOMITANT MEDICAL PRODUCTS: ALSO LOT #H8739702; MFG DATE 05/2013; EXPIRATION DATE 05/08/2017. THE DEVICES IN QUESTION WERE ANALYZED BY QUALITY ENGINEER. RECEIVED TWO (2) SAMPLE(S) WITH ORIGINAL OPENED PRODUCT POUCHES AND PRODUCT LABELS IDENTIFYING BOTH SAMPLES AS PART NUMBER 1882940HR - INFERIOR TURBINATE BLADE 2.9MM FROM LOTS H8672833 AND H8739702. THE CONDITION OF THE SAMPLES SHOWED CUSTOMER USE BASED ON THE BIO-RESIDUE PRESENT ON THE OUTER SHAFTS. BOTH SAMPLES WERE FOUND TO INDICATE IDENTICAL FAILURES AS BOTH SAMPLES HAS BROKEN INNER SHAFT ASSEMBLY. THE BROKEN INNER SHAFT MEASURED APPROXIMATELY 1.4CM FROM THE PROXIMAL END OF THE INNER HUB. THE INNER SHAFT APPEARED TO HAVE CIRCULAR INDENTATION MARKS WHICH ARE INDICATIVE OF AGGRESSIVE HANDLING / USE OF THE DEVICE BY CUSTOMER AND/OR DUE TO LONG RUN TIME OF THE DEVICE. THE REMAINING PORTION OF THE INNER SHAFT CONTAINED INSIDE THE OUTER SHAFT COULD NOT BE RETRIEVED ON BOTH SAMPLES. NO LOADING ISSUES WERE NOTED ON THE HUBS. THE OUTER DIAMETER OF THE BROKEN INNER SHAFT PIECE MEASURED APPROXIMATELY 0.083" WHICH IS WITHIN THE REQUIRED SPECIFICATION OF 0.083" +/- .001 AS PER DRAWING 11681535 REV. D. MFG DATE: 03/2017 (B)(4).

    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 TWO (2) INFERIOR TURBINATE BLADES BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322462 INFERIOR TURBINATE BLADE 2.9MM BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1882940HR H8672833

    Patients

    Seq Age Sex Outcome Treatment
    1