BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK BIOINTRAFIX HEX DRIVER, 30MM

    MDR report key: 3575904 · Received January 15, 2014

    Report

    Report Number
    1221934-2014-00003
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 6, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    LHX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF 91 DEVICES THAT WERE RELEASED TO DISTRIBUTION ON (B)(6) 2011. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY 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

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK HOWEVER 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.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THE FOLLOWING TO US: DR (B)(6) ¿HAD A MULTI-LIGAMENT PROCEDURE WHERE HE WAS REPAIRING THE ACL, PCL AND POSTERO-LATERAL CORNER. AT THE END OF THE PROCEDURE WHEN HE WAS FIXING THE TIBIAL SIDE OF THE ACL WITH BIO-INTRAFIX, THE MODULAR HEX DRIVER BROKE IN-SITU. HE WAS USING AN 8-10 SCREW AND HE SAID THE FIT WAS VERY TIGHT IN THE TUNNEL. THE LENGTH OF THE DRIVER BROKE UP THE ENTIRE CENTRE OF THE SCREW. AS HE WAS HAPPY WITH THE FIXATION OF THE SCREW, TUNNEL SIZE AND POSITION HE DID NOT WANT TO ATTEMPT TO TAKE THE SCREW OUT SO IN THE END HE HAD TO USE A BURR TO TAKE OFF THE END OF THE SCREW IN ORDER TO WIDEN THE CANNULATION TO REMOVE THE METAL SCREW DRIVER¿. NOTHING IS BEING RETURNED AND THEY ARE REPORTING NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38787 MITEK BIOINTRAFIX HEX DRIVER, 30MM ARTHROSCOPIC INSTRUMENT LHX DEPUY MITEK NA 1101001

    Patients

    Seq Age Sex Outcome Treatment
    1