BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2212831 · Received August 16, 2011

    Report

    Report Number
    1056128-2011-00076
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 19, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    HRX
    PMA / PMN Number
    K012611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SLIGHT GALLING ON THE INNER SHAFT AND A BENT OUTER AND INNER SHAFT. METAL PARTICULATES WERE OBSERVED ON THE INNER SHAFT AND INSIDE THE OUTER SHAFT HUB. THE GALLING MARKS ON THE DEVICE INDICATE EXCESSIVE LATERAL OR "SIDE-LOADING" OF THE DEVICE. THIS CAN CAUSE DAMAGE TO THE DEVICE AND THE EMISSION OF METAL SHAVINGS CAN OCCUR. STRYKER SUSTAINABILITY SOLUTIONS' INSTRUCTIONS FOR USE STATES, "DO NOT APPLY EXCESSIVE PRESSURE OR "SIDE-LOAD" THE BLADE DURING USE. SIDE-LOADING DOES NOT IMPROVE THE PERFORMANCE OF THE INSTRUMENT, CAN DULL THE BLADE, AND/OR PRODUCE METAL PARTICULATES." THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED AND THE DEVICE WAS RETURNED WITHOUT ANY OF THE DEVICE LABELING. HOWEVER, 100% INSPECTION IS PERFORMED PRIOR TO THE REPROCESSED DEVICES BEING RELEASED. 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 KNEE SCOPE PROCEDURE THE ARTHROSCOPIC BLADE WAS PRODUCING 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 STRYKER SUSTAINABILITY SOLUTIONS 7205305 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR