BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW SELF TAPPING

    MDR report key: 2093923 · Received April 19, 2011

    Report

    Report Number
    1822565-2011-00974
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ZIMMER
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THE INNER PACKAGE AND FOLDABLE CARTON WERE RETURNED FOR REVIEW; THE OUTER PACKAGE WAS NOT. A HOLE WAS FOUND IN THE INNER TYVEK LID, LOCATED JUST INSIDE OF THE HEAT SEAL. EXAMINATION FOUND THE HOLE TO BE TEARDROP SHAPED WITH TVEK MATERIAL BUNCHED UP TO THE ONE SIDE OF THE HOLE. WITH THE INFORMATION PROVIDED, IT CANNOT BE CONFIRMED THAT THE TYVEK LID ON THE INNER CAVITY CONTAINED A HOLE WHEN INITIALLY REMOVED FROM THE OUTER PACKAGE. EVEN IF THE INNER TYVEK LID CONTAINED A HOLE, ITS CONTENTS WOULD REMAIN STERILE AS IT IS CONTAINED WITHIN A STERILE OUTER PACKAGE. NO OTHER COMPLAINTS HAVE BEEN RETURNED FROM THIS PARTICULAR LOT. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW'S INNER PACKAGE HAD A HOLE IN IT, WHILE THE OUTER PACKAGE HAD NO DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREW SELF TAPPING HWC ZIMMER 61717213

    Patients

    Seq Age Sex Outcome Treatment
    1