BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISPAN MENISCAL APPLIER

    MDR report key: 1963390 · Received January 14, 2011

    Report

    Report Number
    1221934-2011-00012
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 3, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. THE COMPLAINTS ENGINEER AND THE QAE ASSOCIATED WITH THIS PRODUCT LINE BOTH EXAMINED THE DEVICE; VISUALLY, THE DEVICE APPEARS IN THE READY TO USE CONDITION, NO DAMAGE AND NO ANOMALIES. FUNCTIONALLY, THE DEVICE PERFORMED AS DESIGNED AND MANUFACTURED; THEY COULD NOT DUPLICATE THE REPORTED MALFUNCTION. BOTH TRIGGERS WORKED SMOOTHLY AND ACTUATED THE SPRING MECHANISM; THEY COULD FIND NO FAULT WITH THE DEVICE. 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 COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE BELIEVE THAT THE ROOT CAUSE FOR THE REPORTED ADVERSE EVENT LIES OUTSIDE OF ANY PROBLEMS OR DEFECTS WITH THE COMPLAINT DEVICE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, 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.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR, WHILE DEPLOYING THE MENISCAL APPLIER TO FACILITATE FIXATION, THE APPLIER FIRED THE 1ST FASTENER SUCCESSFULLY, HOWEVER, IT JAMMED DURING THE ATTEMPT TO DEPLOY THE SECOND FASTENER. AT THIS POINT THE SURGEON REMOVED THE APPLIER FROM THE JOINT AND IN DOING SO, THE MENISCUS WAS FURTHER DAMAGED. THE SURGEON RESORTED TO PERFORMING A PARTIAL MENISECTOMY FOR REMEDY. THIS REMEDY WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THE REP STATES THAT THE TRIGGERS WERE PULLED CORRECTLY AND THE NEEDLES WERE LOADED CORRECTLY. FASTENERS DISCARDED, APPLIER BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN MENISCAL APPLIER MENISCAL INSTRUMENT HRX DEPUY MITEK 228143 3469084

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention