BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION CARTG(18.3X1.33X105)

    MDR report key: 2102973 · Received May 12, 2011

    Report

    Report Number
    9616696-2011-00077
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MFR FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE PACKAGING HAD BEEN DAMAGED. THE MFG HISTORY RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE LABEL FOR THIS DEVICE HAS A SYMBOL INDICATING "STERILE ONLY IF PACKAGE IS UNOPENED AND UNDAMAGED". THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING OF THE BLADE WAS DAMAGED. IT WAS ALSO REPORTED THAT THE BLADE WAS NOT USED ON A PT AND THE STERILE AREA WAS NOT COMPROMISED. IT WAS FURTHER REPORTED THAT ANOTHER BLADE WAS READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION CARTG(18.3X1.33X105) GFA STRYKER IRELAND LTD. 110300017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK