BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2932357 · Received January 22, 2013

    Report

    Report Number
    2134070-2013-00015
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STERILMED, INC
    Product Code
    HRX
    PMA / PMN Number
    K012536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION WITH NO METAL PITTING OR NOTICEABLE MISSING METAL. THE TEETH OF THE SHAVER WERE NOT DULL OR MISSING ANY METAL. THE DEVICE WAS SUBJECTED TO A DROP TEST AND SPIN TEST, SHOWING NO RUBBING. THE DEVICE WAS RUN ON A GENERATOR FOR FIVE MINUTES, AND AT NO TIME PRODUCED SHAVINGS OR ANY SOUNDS OF GRINDING OR RUBBING. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. THE INSTRUCTIONS FOR USE STATE "EXCESSIVE "SIDE-LOADING" ON THE BLADE DURING USE... MAY RESULT IN WEAR AND DEGRADATION OF THE INNER BLADE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT KNEE ARTHROSCOPY METAL SHAVINGS WERE FOUND IN THE SURGERY SITE. THE PROCEDURE WAS DELAYED WHILE A "WASHOUT" WAS PERFORMED TO CLEAN THE SITE. THE SHAVINGS WERE REMOVED. THE PROCEDURE WAS COMPLETED, AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31634 NA HRX STERILMED, INC SMI7205345

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR