BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK OMNISPAN MENISCAL APPLIER

    MDR report key: 3061052 · Received April 16, 2013

    Report

    Report Number
    1221934-2013-00111
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    GEF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FAILURE MODE WAS INVESTIGATED UPON RECEIVING THE RETURNED APPLIER. BOTH TRIGGERS (RED AND GRAY) WERE TESTED FOR FUNCTIONALITY. BOTH TRIGGERS FUNCTIONED PROPERLY WHEN PULLED ON THEIR OWN WITHOUT A NEEDLE ATTACHED TO THE DEVICE. THE APPLIER WAS LOADED WITH AN OMNISPAN 27 DEGREES NEEDLE (P/N (B)(4), LOT 3653488) WITH NO INCIDENT. THE APPLIER WAS ABLE TO SUCCESSFULLY DEPLOY THE 1ST IMPLANT (GRAY TRIGGER), LOAD THE 2ND IMPLANT (RED TRIGGER), AND DEPLOY THE 2ND IMPLANT (GRAY TRIGGER) WITHOUT ANY INCIDENT. THIS SEQUENCE WAS REPEATED USING AN OMNISPAN 12 DEGREES NEEDLE (P/N (B)(4), LOT 3682748) WITH NO INCIDENT. THE DEVICE WAS THEN DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS. IT WAS DETERMINED THAT THE DEVICE WAS ASSEMBLED CORRECTLY AND ALL COMPONENTS FUNCTIONED PROPERLY, THEREFORE THESE WERE NOT IDENTIFIED AS THE ROOT CAUSE OF THIS COMPLAINT. THE GRAY TRIGGER AND PUSHER ROD WERE EXAMINED MORE CLOSELY FOR POTENTIAL RESISTANCE, JAMMING, OR DOUBLE DEPLOYMENT (WITH RED TRIGGER COMPONENTS REMOVED). THESE COMPONENTS FUNCTIONED PROPERLY TO DEPLOY IMPLANTS UTILIZING THE PUSHER ROD AND HAD NO INTERFERENCE THAT COULD POTENTIAL RESULT IN DEPLOYING BOTH IMPLANTS, THEREFORE THESE WERE NOT IDENTIFIED AS THE ROOT CAUSE OF THIS COMPLAINT. THE FAILURE MODE WAS UNABLE TO BE CONFIRMED, BUT NO EVIDENCE OF DEPLOYING BOTH IMPLANTS WAS FOUND, WHICH WAS THE FAILURE MODE DESCRIBED IN THE COMPLAINT. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED AND TRACKED THROUGH THE (B)(4). AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO, 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

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT. AWAITING RETURN.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR WITH THE USE OF AN OMNISPAN SYSTEM FOR FASTENING, THE SURGEON EXPERIENCED A SERIES OF DEPLOYMENT ISSUES WITH THE SYSTEM WHICH LED TO A PARTIAL MENISECTOMY FOR REMEDY. IT APPEARS THAT WHEN THE SURGEON PULLED THE 1ST TRIGGER OF THE APPLIER, BOTH FASTENERS ON THE INSERTER NEEDLE DEPLOYED AT ONCE; THIS HAPPENED TO 4 SEPARATE FASTENER DEVICES. THE SURGEON DECIDED TO PERFORM A PARTIAL MENISCECTOMY FOR REMEDY. ALSO SEE ASSOCIATED MDRS 1221934-2013-00107, 1221934-2013-00108, 1221934-2013-00109 AND 1221934-2013-00110.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162144 MITEK OMNISPAN MENISCAL APPLIER MENISCAL INSTRUMENT GEF DEPUY MITEK NA 3503123

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention