BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MBT TIBIAL IMPACTOR

    MDR report key: 3972610 · Received August 1, 2014

    Report

    Report Number
    1818910-2014-24538
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    FOLLOWING INVESTIGATION BY THE SUPPLIER, IT WAS IDENTIFIED THAT CHEMICAL ATTACK WAS LIKELY TO BE CAUSING THE CRACKING OF THE HANDLE MATERIAL DURING HOSPITAL PROCESSING. A NEW MATERIAL IS NOW TO BE USED FOLLOWING RECOMMENDATIONS FROM THE RAW MATERIAL SUPPLIER. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    HANDLE WAS CRACKED. THIS INCIDENT WAS FOUND AT INSPECTION IN OUR WAREHOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450269 MBT TIBIAL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY INTERNATIONAL LTD. 8010379 081917

    Patients

    Seq Age Sex Outcome Treatment
    1