BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOKNOTLESS RAPIDE W/ ORTHOCORD

    MDR report key: 1022481 · Received March 31, 2008

    Report

    Report Number
    1221934-2008-00162
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 13, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVAL. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF 200 DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN HOW THE DEVICE WAS DAMAGED OR WHAT PRECIPITATED ITS DAMAGE.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR WHILE ATTEMPTING TO DEPLOY THE FIXATION DEVICE INTO THE BONE HOLE, IT SOMEHOW BECAME DAMAGED. THE SURGEON NOTED THIS, AND IN THE ATTEMPTED TO DRAW THE ANCHOR BACK THROUGH THE CANNULA. WHEN THE ANCHOR ASSEMBLY WAS WITHDRAWN A PORTION OF DISTAL END OF THE ANCHOR WAS MISSING, HAD BROKEN OFF. THEY DO NOT KNOW WHERE THIS FRAGMENT IS, MAY RESIDE WITHIN THE PT'S JOINT SPACE. THIS PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOKNOTLESS RAPIDE W/ ORTHOCORD SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 212722 3067977

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK