BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK OMNISPAN MENISCAL APPLIER

    MDR report key: 3761466 · Received April 21, 2014

    Report

    Report Number
    1221934-2014-00150
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 22, 2014
    Report Date
    March 24, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. 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 DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED FOUR OTHER DISSIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. A REVIEW OF THE STERILIZATION LOAD RECORDS FOR THIS LOT REVEALED THERE WERE 5 LOTS OF PRODUCT CONTAINING (B)(4) DEVICES STERILIZED. A REVIEW OF THE COMPLAINT SYSTEM REVEALED AS OF (B)(6) 2014 THERE WERE NO OTHER REPORTED PATIENT INFECTION COMPLAINTS FOR ANY OTHER DEVICE FROM THIS STERILIZATION LOAD. BASED ON THE DEPTH AND BREADTH OF OUR INVESTIGATION AS DESCRIBED ABOVE, WE DO NOT BELIEVE THE ROOT CAUSE LIES WITH THE MITEK MANUFACTURING OR QUALITY SYSTEMS, OR THAT THE REPORTED PATIENT INFECTION WAS CAUSED BY THE COMPLAINT DEVICE. DEPUY SYNTHES (B)(4) HAS INSTRUCTED OUR AFFILIATE TO INFORM THE HOSPITAL OF OUR INVESTIGATION RESULTS SO THAT THEY CAN LOOK INTO OTHER POSSIBLE ROOT CAUSES. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES (B)(4) 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

    INFECTION WAS FOUND IN THE PATIENT'S KNEE POST ACL RECONSTRUCTION SURGERY 3 WEEKS AGO. DEBRIDEMENT AND WASH OUT SURGERY WAS DONE ON (B)(6) 2014. IMPLANTS (BIOINTRAFIX AND SOFT TISSUE FEMORAL INTRAFIX, PRODUCT CODE AND LOT NUMBER WERE UNKNOWN FOR NOW, NEED TO FOLLOW-UP WITH REPORTER) WERE NOT REMOVED. PATIENT HAS DISCHARGED. THE SURGEON COULD NOT ASCERTAIN THAT THE INFECTION WAS ATTRIBUTED TO THE IMPLANTS. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON 4-1-14; THE SURGEON DID A WASH OUT, DID NOT REMOVE THE IMPLANTS, AND THE PATIENT WAS DISCHARGED WITH ANTIBIOTICS. SEE ASSOCIATED MEDWATCH NUMBERS 1221934-2014-00147, 1221934-2014-00148, 1221934-2014-00149, 1221934-2014-00151, AND 1221934-2014-00152.

    Description of Event or Problem · 1

    INFECTION WAS FOUND IN THE PATIENT'S KNEE POST ACL RECONSTRUCTION SURGERY 3 WEEKS AGO. DEBRIDEMENT AND WASH OUT SURGERY WAS DONE ON (B)(6) 2014. IMPLANTS (BIOINTRAFIX AND SOFT TISSUE FEMORAL INTRAFIX, PRODUCT CODE AND LOT NUMBER WERE UNKNOWN FOR NOW, NEED TO FOLLOW-UP WITH REPORTER) WERE NOT REMOVED. PATIENT HAS DISCHARGED. THE SURGEON COULD NOT ASCERTAIN THAT THE INFECTION WAS ATTRIBUTED TO THE IMPLANTS. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON (B)(4) 2014; THE SURGEON DID A WASH OUT, DID NOT REMOVE THE IMPLANTS, AND THE PATIENT WAS DISCHARGED WITH ANTIBIOTICS. SEE ASSOCIATED MEDWATCH NUMBERS 1221934-2014-00147, 1221934-2014-00148, 1221934-2014-00149, 1221934-2014-00151, AND 1221934-2014-00152.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239706 MITEK OMNISPAN MENISCAL APPLIER MENISCAL IMPLANT APPLIER GEF DEPUY MITEK NA 3724886

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention