BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK OMNISPAN MENISCAL APPLIER

    MDR report key: 3910065 · Received July 2, 2014

    Report

    Report Number
    1221934-2014-00270
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS DISCARDED AT THE FACILITY AND THEREFORE NOT AVAILABLE FOR EVALUATION. THE EVENT REPORTED INDICATES THERE COULD HAVE BEEN A POTENTIAL ISSUE WITH THE OMNISPAN APPLIER AND NOT THE ASSOCIATED NEEDLE (MEDWATCH # 1221934-2014-00271). HOWEVER, WITHOUT PHYSICALLY EVALUATING THE DEVICES, THE EXACT FAILURE OR THE ROOT CAUSE CANNOT BE DETERMINED. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. THE 12 MONTH COMPLAINT RATE FOR THIS FAILURE WAS REVIEWED AGAINST THE RISK ANALYSIS DOCUMENT AND FOUND TO BE WITHIN THE EXPECTED LEVELS. THEREFORE, AT THIS POINT IN TIME, NO 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 SALES REP REPORTED THAT AFTER SUCCESSFULLY DEPLOYING THE FIRST IMPLANT OF AN OMNISPAN MENISCAL REPAIR SYSTEM 12 DEGREE NEEDLE, THE SECOND IMPLANT BECAME STUCK ON THE OMNISPAN APPLIER WHEN THE SURGEON TRIED TO DEPLOY IT. THE SALES REP REPORTED THE PATIENT¿S TIGHT JOINT SPACE CONTRIBUTED TO THE SURGEON OVER PENETRATING THE MENISCUS. THE SURGEON COMPLETELY REMOVED THIS IMPLANT BY PULLING IT OUT BY THE SUTURES AND AT THIS POINT PERFORMED A MENISCECTOMY DUE TO THE LACK OF GOOD TISSUE AVAILABLE TO APPLY A SECOND IMPLANT. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER HARM TO THE PATIENT. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE. THE CUSTOMER ALREADY DISCARDED THE DEVICES. SEE ASSOCIATED MEDWATCH # 1221934-2014-00271.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386310 MITEK OMNISPAN MENISCAL APPLIER MENISCAL APPLIER GEF DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1