BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED ROUTER, MEDIUM D-48

    MDR report key: 2152491 · Received June 21, 2011

    Report

    Report Number
    9616696-2011-00100
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 25, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SUBJECT TO THIS INVESTIGATION WAS RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE PACKAGING MATERIAL WAS BRITTLE. THE LABEL FOR THIS DEVICE HAS A SYMBOL INDICATING "STERILE ONLY IF PACKAGE IS UNOPENED AND UNDAMAGED". AN ALTERNATIVE PACKAGING MATERIAL HAS SINCE BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE UNPACKING A SHIPMENT, IT WAS NOTED THAT THE PACKAGING OF THE DEVICE WAS CRACKED. IT WAS ALSO REPORTED THAT THE DEVICE WAS NOT USED ON A PT AND THE STERILE AREA WAS NOT COMPROMISED. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED ROUTER, MEDIUM D-48 HWE STRYKER IRELAND LTD. 08112017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK