BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT RIGHT ANGLE DRIVE

    MDR report key: 2851171 · Received October 29, 2012

    Report

    Report Number
    1811755-2012-03943
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    August 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT WITHOUT AN EVAL OF THE DEVICE. ADDITIONAL INFO WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, METAL SHAVING FELL OUT OF THE RADIOLUCENT RIGHT ANGLE DRIVE. NO FURTHER INFO WAS PROVIDED; NO ADVERSE CONSEQUENCES WAS ASSOCIATED WITH THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A READILY AVAILABLE ALTERNATE ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOLUCENT RIGHT ANGLE DRIVE HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK