BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMOOTH GUIDE WIRE BULLET TIP

    MDR report key: 1860207 · Received September 21, 2010

    Report

    Report Number
    1822565-2010-00801
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IT IS SUSPECTED THAT PRODUCT WAS OPENED SOMEWHAT IN DISTRIBUTION ENVIRONMENT AND REMOVED FROM STERILE POUCH, PRODUCT WAS THEN PLACED BACK INTO CARTON AND SEALED AND PLACED BACK INTO DISTRIBUTION ENVIRONMENT. THE PRODUCT WAS MOST LIKELY PREVIOUSLY OPENED AND RESEALED INTO CARTON OUTSIDE OF ZIMMER CONTROLLED DISTRIBUTION ENVIRONMENT. A CAUSE CANNOT BE DEFINITIVELY DETERMINED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPEC. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON OPENING, THE GUIDE WIRE WAS NOT ENCLOSED IN STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOOTH GUIDE WIRE BULLET TIP TRAUMA INSTRUMENT LXH ZIMMER, INC. 61251265

    Patients

    Seq Age Sex Outcome Treatment
    1