BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTMIX TOWER CARTRIDGE

    MDR report key: 646891 · Received November 16, 2005

    Report

    Report Number
    1818910-2005-02449
    Event Type
    Other
    Date Received
    November 16, 2005
    Date of Event
    October 25, 2005
    Report Date
    October 25, 2005
    Manufacturer
    DEPUY CMW
    Product Code
    KIH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS REVIEWED AT DEPUY AND BY THE SUPPLIER TO CONFIRM THE COMPLAINT WITH EVIDENCE OF THE ALLEGED PRODUCT DEFICIENCY. THE ROOT CAUSE COULD NOT BE DETERMINED. SUPPLIER COMMENCED A REVIEW OF THE MANUFACTURING RECORDS, AND CONFIRMED THAT THE IN-PROCESS PACKAGE INTEGRITY TESTS (BURST TEST) WERE COMPLETE IN ACCORDANCE WITH REQUIREMENTS, AND SHOW ALL RESULTS TO BE IN EXCESS OF THE MINIMUM LEVEL FOR THIS PACK. THE VALIDATED PACKAGING PROCESS (INCLUDING TRANSIT TRIALS) HAS BEEN REVIEWED, AND NO CONCERNS HAVE BEEN IDENTIFIED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    COMPROMISED STERILE PACKAGING FOUND IN THE OPERATING ROOM. NO SIGNIFICANT EXTENSION OF SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTMIX TOWER CARTRIDGE CEMENT ACCESSORIES KIH DEPUY CMW NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA