BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE

    MDR report key: 3060974 · Received April 16, 2013

    Report

    Report Number
    1221934-2013-00108
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K092836
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING WAS RECEIVED FOR EVALUATION; HOWEVER, 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 SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT TELL ANYTHING FROM THIS; CANNOT DISCERN THE UNDERLYING OR ROOT CAUSE FOR THE REPORTED DEVICE¿S FAILURE MODE. 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

    NOTHING WAS RECEIVED FOR EVALUATION; HOWEVER, 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 SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT TELL ANYTHING FROM THIS; CANNOT DISCERN THE UNDERLYING OR ROOT CAUSE FOR THE REPORTED DEVICE¿S FAILURE MODE. 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.

    Additional Manufacturer Narrative · 1

    NOTHING WAS RECEIVED FOR EVALUATION; HOWEVER, 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 SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT TELL ANYTHING FROM THIS; CANNOT DISCERN THE UNDERLYING OR ROOT CAUSE FOR THE REPORTED DEVICE¿S FAILURE MODE. 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.

    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, 1221934-2013-00109, 1221934-2013-00110 AND 1221934-2013-00111.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163728 MITEK OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE MENISCAL FASTENER MBI DEPUY MITEK NA 3593128

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention