BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURRS

    MDR report key: 3013280 · Received March 20, 2013

    Report

    Report Number
    1219602-2013-00068
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FUNCTIONAL TESTING WAS PERFORMED AND IT WAS CONFIRMED THAT THE BUSHING ROTATES. VISUAL INSPECTION CONFIRMED THAT THE BATCH WAS NOT DE-BURRED AND THERE WAS DAMAGE TO THE HUB/SLUFF. THE ROOT CAUSE OF THIS SHEDDING AND/OR SEIZING IS ONGOING, (B)(4) HAS BEEN OPENED TO INVESTIGATE THE ROOT CAUSE AND SUPPLY APPLICABLE CORRECTIVE ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY AND SUBACROMIAL DECOMPRESSION PROCEDURE THERE WAS HEAVY FLAKING OF METAL IN THE JOINT WHEN USED. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. IT WAS REPORTED THAT THE METAL DEBRIS FLAKING WAS LEFT BEHIND. SALES REP. WAS NOT PRESENT DURING THE PROCEDURE BUT LATER HE OBSERVED HEAVY SCORING ON THE INNER PORTION OF THE BURR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115660 BURRS DYONICS 4.0MM ELITE ACROMIONIZER BURR HAB MANSFIELD MANUFACTURING SITE 72200724 50704284

    Patients

    Seq Age Sex Outcome Treatment
    1