BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1942400 · Received December 30, 2010

    Report

    Report Number
    1056128-2010-00101
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ASCENT
    Product Code
    HRX
    PMA / PMN Number
    K012605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE RETURNED DEVICE PASSED ALL FUNCTION TESTING, THE VISUAL EXAMINATION OF THE DEVICE REVEALED GALLING MARKS ALONG THE INNER SHAFT. METAL PARTICULATES WERE ALSO OBSERVED ON THE INNER SHAFT. THE GALLING MARKS ON THE DEVICE INDICATE EXCESSIVE LATERAL OR "SIDELOADING" OF THE DEVICE. THIS CAN CAUSE DAMAGE TO THE DEVICE AND THE EMISSION OF METAL SHAVINGS CAN OCCUR. ASCENT'S INSTRUCTIONS FOR USE STATES: "DO NOT APPLY EXCESSIVE PRESSURE OR "SIDE-LOAD" THE BLADE DURING USE. SIDE-LOADING DOES NOT IMPROVE PERFORMANCE OF THE INSTRUMENT, CAN DULL THE BLADE, AND/OR PRODUCE METAL PARTICULATES." THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE BUR PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AN ARTHROSCOPIC BUR PRODUCED METAL SHAVINGS. NOT ALL OF THE SHAVINGS WERE REMOVED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A HRX HRX ASCENT 375-941-000 1227257

    Patients

    Seq Age Sex Outcome Treatment
    1