BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MBT TIBIAL IMPACTOR

    MDR report key: 3911461 · Received July 3, 2014

    Report

    Report Number
    1818910-2014-22598
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF HANDLE DAMAGE. PREVIOUS INVESTIGATIONS HAVE BEEN CONDUCTED FOR HANDLE BREAKAGE/CRACKING OF PRODUCT CODES (B)(4) MBT TIBIAL IMPACTOR. FOLLOWING THE PREVIOUS INVESTIGATIONS BY THE SUPPLIER, IT WAS IDENTIFIED THAT CHEMICAL ATTACK WAS LIKELY TO BE CAUSING THE CRACKING OF THE HANDLE MATERIAL DURING HOSPITAL PROCESSING. THE ROOT CAUSE IS ATTRIBUTED TO SUPPLIER MATERIAL. THE SUPPLIER IS UTILIZING A NEW MATERIAL IS BEING USED FOLLOWING RECOMMENDATIONS FROM THE RAW MATERIAL SUPPLIER. THE MATERIAL HAS BEEN CHANGED AND THE IMPLEMENTATION DATE OF THE NEW MATERIAL WAS (B)(4) 2010. THE COMPLAINT SAMPLE WAS MANUFACTURED PRIOR THE MATERIAL CHANGE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    HANDLE CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390022 MBT TIBIAL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 072228

    Patients

    Seq Age Sex Outcome Treatment
    1