BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_INSTRUMENTS_PRODUCT

    MDR report key: 3201063 · Received July 2, 2013

    Report

    Report Number
    0001811755-2013-01542
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NOT RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN STRYKER HANDPIECE WAS BEING USED IN A LEFT FOOT CHEVRON SURGERY WHEN A BLACK PARTICLE CAME OUT AND WENT INTO THE SURGICAL SITE. THE PARTICLE WAS REMOVED WITH IRRIGATION AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303326 UNKNOWN_INSTRUMENTS_PRODUCT UNKNOWN DEVICE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1