BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2438275 · Received February 3, 2012

    Report

    Report Number
    1056128-2012-00007
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 9, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    HRX
    PMA / PMN Number
    K012346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED GALLING MARKS ON THE DISTAL TIP OF THE OUTER SHAFT AND ON THE INNER SHAFT. DAMAGE WAS OBSERVED ON THE DISTAL TIP OF THE OUTER SHAFT. METAL PARTICULATES WERE OBSERVED ON THE INNER AND OUTER SHAFTS. THE DEVICE PASSED ALL FUNCTION TESTING THAT TESTED FOR BENDS IN THE DEVICE AND STRAIGHTNESS. THE DEVICE DID NOT HAVE ANY DEFORMATION ON EITHER THE INNER OR OUTER SHAFT THAT WOULD SUGGEST AREAS WHERE UNWARRANTED FRICTION COULD OCCUR. 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 PERFORMANCE OF THE INSTRUMENT, CAN DULL THE BLADE, AND/OR PRODUCE METAL PARTICULATES." THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE COMPLAINT DEVICE 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 SHOULDER ARTHROSCOPY PROCEDURE, THE ARTHROSCOPIC BLADE EMITTED METAL SHAVINGS INTO THE JOINT. NOT ALL OF THE SHAVINGS WERE REMOVED. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A HRX HRX STRYKER SUSTAINABILITY SOLUTIONS 9263A 1448316

    Patients

    Seq Age Sex Outcome Treatment
    1