BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2241808 · Received September 9, 2011

    Report

    Report Number
    1056128-2011-00089
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 15, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    HRX
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. THE DEVICE PACKAGING WAS NOT SAVED EITHER SO INFORMATION SUCH AS ITEM NUMBER, LOT NUMBER, MANUFACTURE DATE, AND EXPIRATION DATE ARE ALL UNKNOWN. SINCE THE DEVICE WAS NOT RETURNED FOR AN EVALUATION A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, PRIOR TO RELEASE, 100% OF ALL ARTHROSCOPIC DEVICES ARE FUNCTION TESTED. SSS'S INSTRUCTIONS FOR USE STATES, "CAREFUL HANDLING OF THE INSTRUMENT IS NECESSARY TO AVOID DAMAGE OR BREAKAGE AS A RESULT OF EXCESSIVE FORCE." 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 AT THE END OF A SHOULDER ARTHROSCOPY PROCEDURE THE ARTHROSCOPIC BURR FELL APART. NOTHING REMAINED IN THE PATIENT AND NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1