BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL APPLIER

    MDR report key: 2140535 · Received June 27, 2011

    Report

    Report Number
    1221934-2011-00250
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED 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 COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. OUR AFFILIATE STATES THAT A COMPANY REPRESENTATIVE WAS PRESENT DURING THIS CASE, AND THE REP STATES THAT TECHNIQUE, A USER ISSUE WAS THE DRIVING FORCE BEHIND THE EXTENDED SURGERY TIME; OUTSIDE OF THAT WE CANNOT DISCERN ANY OTHER ROOT OR UNDERLYING CAUSE FOR THE DELAY IN SURGERY. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE AND CLARIFYING 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.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR WITH THE USE OF OMNISPAN FOR MENISCAL FASTENING, THERE WERE SOME DEPLOYMENT ISSUES THAT INFLUENCED THE PROCEDURE TO BE EXTENDED BY 40 MINUTES. ON TWO OF THE FASTENERS, THE SILICONE RETENTION TUBING EITHER CRACKED OR BECAME LOOSE, WHICH RESULTED IN THE PREMATURE RELEASE OF THE BACKSTOPS. ON ONE OF THE DEPLOYMENT ATTEMPTS, IT APPEARS THAT THE DEPLOYMENT GUN FAILED TO ACTIVATE; IT SOMEHOW BOUND UP. THE REPORT STATES THAT NOTHING FELL INTO THE PATIENT'S BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT, HOWEVER, THE PROCEDURE WAS EXTENDED BY 40 MINUTES. ALSO SEE ASSOCIATED MDRS 1221934-2011-00247, 1221934-2011-00248 AND 1221934-2011-00249.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN MENISCAL APPLIER MENISCAL APPLIER MBI DEPUY MITEK NA 3484634

    Patients

    Seq Age Sex Outcome Treatment
    1