BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO INTERFERENCE SCREW, 8MM X 23MM

    MDR report key: 1970009 · Received January 14, 2011

    Report

    Report Number
    1221934-2011-00013
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 21, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK RECEIVED AN UNUSED DEVICE OF THE SAME STILL IN ITS UNOPENED PACKAGING; DID NOT RECEIVE THE COMPLAINT DEVICE. THE RECEIVED DEVICE WAS EXAMINED AND IT WAS IN PRISTINE CONDITION; NO FAULTS OR ANOMALIES NOTED. 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, IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO SIMILAR COMPLAINTS FOR THIS LOT 791 OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT OR UNDERLYING CAUSE FOR THE REPORTED DEVICE FAILURE. AT THIS POINT IN TIME, NO FURTHER OR CORRECTIVE ACTION IS WARRANTED, HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC KNEE REPAIR, THE MILAGRO FIXATION SCREW BROKE APART WHILE THE SURGEON WAS DRIVING IT INTO THE BONE TUNNEL. THE SURGEON WAS NOT ABLE TO RETRIEVE THE DISTIL THIRD OF THE DEVICE; THE FRAGMENT IS PROVIDING FIXATION. OUTSIDE OF THIS ANOMALY, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. DUE TO THIS, THE SURGEON FOR THIS PATIENT HAS CHANGED THE REHAB PROTOCOL TO INSURE THE INTEGRITY OF THE REPAIR AND ITS HEALING; REHAB IS EXTENDED TO 12 WEEKS WITH NO WEIGHT BEARING AND NO RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILAGRO INTERFERENCE SCREW, 8MM X 23MM SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 231810 3465786

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK