BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK NON ABSORBABLE ANCHOR IMPLANT

    MDR report key: 2930016 · Received January 25, 2013

    Report

    Report Number
    1221934-2013-00025
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 28, 2010
    Report Date
    January 25, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    PMA / PMN Number
    K915889
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS FOLLOW-UP MEDWATCH REPORT IS TO CORRECT A TYPING ERROR TO THE PRODUCT CODE ON THE PREVIOUS FOLLOW-UP REPORT. THE PRODUCT CODE WAS CORRECTED TO 212133 FROM 212134. I APOLOGIZE FOR ANY INCONVENIENCE THIS MAY HAVE CAUSED.

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS FOLLOW-UP MEDWATCH REPORT IS TO UPDATE THE PRODUCT CODE AND LOT NUMBER. 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. (B)(4). WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    TO DATE THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED FOR VISUAL AND FUNCTIONAL INSPECTION. PRODUCT CODE(S) AND BATCH NUMBER(S) HAVE NOT BEEN PROVIDED TO PRECISELY IDENTIFY THE DEPUY MITEK GII ANCHOR AND THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED AT THIS TIME TO DETERMINE IF THERE WERE ANY MANUFACTURING RELATED ISSUES. WHEN AND IF ANY ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REVIEWED AND EVALUATED AND THE DETAILS WILL BE INCLUDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT IS BEING REPORTED A MITEK GII ANCHOR WAS USED TO REATTACH TENDONS TO THE NAVICULAR BONE. THE GII ANCHOR REPORTEDLY BROKE INTO PIECES CAUSING A FRACTURE IN THE NAVICULAR BONE. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35649 MITEK NON ABSORBABLE ANCHOR IMPLANT GII ANCHOR JDR DEPUY MITEK NA 3361637

    Patients

    Seq Age Sex Outcome Treatment
    1