BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE

    MDR report key: 3233989 · Received July 18, 2013

    Report

    Report Number
    1221934-2013-00181
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K092836
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    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.

    Additional Manufacturer Narrative · 1

    43 DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK; THE COMPLAINT DEVICE IS NOT BEING RETURNED, WHICH PRECLUDES CONDUCTING AN 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; WE CANNOT DISCERN A ROOT OR UNDERLYING CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT 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 REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR WITH THE USE OF OMNISPAN ON A (B)(6) ATHLETIC MALE WITH EXCEPTIONAL BONE QUALITY, THE SURGEON, WHO IS AN EXPERIENCED OMNISPAN USER, EXPERIENCED A SERIES OF EVENTS IN WHICH IT APPEARS THAT 3 APPLIERS AND 4 FASTENERS SOMEHOW FAILED TO DEPLOY PROPERLY AND CAUSED A 1-2 HOUR DELAY TO THE PROCEDURE. INITIALLY THE 1ST FASTENER OF THE 12 DEGREE TWO FASTENER FIXATION DEVICE DEPLOYED CORRECTLY, HOWEVER, THE SPRING OF THE APPLIER DID NOT RETRACT PRECLUDING THE DEPLOYMENT OF THE 2ND FASTENER; SURGEON LEFT THE 1ST FASTENER IN. A SECOND OMNISPAN APPLIER AND 12 DEGREE FASTENER WERE EMPLOYED, AND AGAIN THE SAME EXACT ISSUE; SURGEON LEFT THE 1ST FASTENER IN. A THIRD OMNISPAN APPLIER AND 12 DEGREE FASTENER WERE EMPLOYED, AND THIS TIME THE 2ND FASTENER DID NOT DEPLOY FAR ENOUGH INTO THE MENISCUS; AGAIN, THE SURGEON LEFT THE 1ST FASTENER IN. THE SURGEON USED THE SAME 3RD APPLIER TO DEPLOY A 27 DEGREE FASTENER WITH THE SAME NEGATIVE RESULTS; 1ST FASTENER LEFT IN MENISCUS. AT THIS POINT THE SURGEON WAS ABLE TO CONCLUDE SUCCESSFULLY USING THE 3RD APPLIER AND ANOTHER 27 DEGREE FASTENER WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. ALL OF THE COMPLAINT DEVICES WERE DISCARDED AT THE USER FACILITY. SEE ALSO ASSOCIATED MDRS 1221934-2013-00180, 1221934-2013-00182, 1221934-2013-00183, 1221934-2013-00184 AND 1221934-2013-00185.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR WITH THE USE OF OMNISPAN ON A (B)(6) ATHLETIC MALE WITH EXCEPTIONAL BONE QUALITY, THE SURGEON, WHO IS AN EXPERIENCED OMNISPAN USER, EXPERIENCED A SERIES OF EVENTS IN WHICH IT APPEARS THAT 3 APPLIERS AND 4 FASTENERS SOMEHOW FAILED TO DEPLOY PROPERLY AND CAUSED A 1-2 HOUR DELAY TO THE PROCEDURE. INITIALLY THE 1ST FASTENER OF THE 12 DEGREE TWO FASTENER FIXATION DEVICE DEPLOYED CORRECTLY, HOWEVER, THE SPRING OF THE APPLIER DID NOT RETRACT PRECLUDING THE DEPLOYMENT OF THE 2ND FASTENER; SURGEON LEFT THE 1ST FASTENER IN. A SECOND OMNISPAN APPLIER AND 12 DEGREE FASTENER WERE EMPLOYED, AND AGAIN THE SAME EXACT ISSUE; SURGEON LEFT THE 1ST FASTENER IN. A THIRD OMNISPAN APPLIER AND 12 DEGREE FASTENER WERE EMPLOYED, AND THIS TIME THE 2ND FASTENER DID NOT DEPLOY FAR ENOUGH INTO THE MENISCUS; AGAIN, THE SURGEON LEFT THE 1ST FASTENER IN. THE SURGEON USED THE SAME 3RD APPLIER TO DEPLOY A 27 DEGREE FASTENER WITH THE SAME NEGATIVE RESULTS; 1ST FASTENER LEFT IN MENISCUS. AT THIS POINT THE SURGEON WAS ABLE TO CONCLUDE SUCCESSFULLY USING THE 3RD APPLIER AND ANOTHER 27 DEGREE FASTENER WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. ALL OF THE COMPLAINT DEVICES WERE DISCARDED AT THE USER FACILITY. SEE ALSO ASSOCIATED MDRS 1221934-2013-00180, 1221934-2013-00182, 1221934-2013-00183, 1221934-2013-00184, 1221934-2013-00185 AND 1221934-2013-00186.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334151 MITEK OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE MENISCAL FASTENER MBI DEPUY MITEK NA 3682748

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR