BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNUM BLADE

    MDR report key: 2460900 · Received February 13, 2012

    Report

    Report Number
    9616696-2012-00031
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MFR FOR EVAL. LOT NUMBER INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE REPAIR UNIT IN (B)(6) THAT THE BROKEN BLADE WAS RECEIVED IN ADDITION TO OTHER DEVICES FROM THE ACCOUNT. IT IS UNK IF THERE WAS ANY PT INVOLVEMENT OF ADVERSE CONSEQUENCES AS A RESULT OF THE BROKEN BLADE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERNUM BLADE DWH STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK