BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK UNKNOWN INTRAFIX

    MDR report key: 3002750 · Received March 13, 2013

    Report

    Report Number
    1221934-2013-00060
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K983560
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVALUATION; COMPLAINT DEVICES DISCARDED AT USER FACILITY. THE ACTUAL CATALOGUE PART IDENTIFICATION OF THE DEVICES CANNOT BE IDENTIFIED, ALSO, NO LOT NUMBERS HAVE BEEN SUPPLIED, WHICH PRECLUDES CONDUCTING A BATCH RECORD REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR AFFILIATE HAS SUPPLIED THE FOLLOWING INFORMATION GIVEN TO THEM BY THE ATTENDING SURGEON: "DR. (B)(6) TOLD ME THAT THE TIBIAL INTRAFIX IMPLANT CAME OUT WITH THE SHEATH ATTACHED AND DID NOT NEED TO BE SCREWED OUT. IT CAME OUT BY JUST PULLING ON THE IMPLANT WITH SOME FORCEPS. THE IMPLANT WAS DISCARDED AS PER HOSPITAL PROTOCOL. DR M. INFORMED ME THAT THERE WAS NO INFECTION. HE ALSO TOLD ME THAT THE ACL GRAFT WAS FUNCTIONING WELL AND WAS TESTED AND ALSO INSPECTED DURING THE KNEE ARTHROSCOPIC PROCEDURE. I DO NOT HAVE ANY DETAIL ON REFERENCE NUMBERS OR LOT NUMBERS OR PRIMARY IMPLANT DATES. DR M. WAS NOT ABLE TO PROVIDE ME WITH THIS INFORMATION." 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.

    Description of Event or Problem · 1

    ALSO SEE ASSOCIATED MDR 1221934-2013-00072.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT A PATIENT UNDERWENT AN INTERVENTION REVISION SURGERY TO REMOVE A MITEK FIXATION DEVICE TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE. THIS IS ALL OF THE INFORMATION THAT HAS BEEN SUPPLIED TO MITEK AT THIS TIME. OUR REPORTING AFFILIATE IS IN THE PROCESS OF GATHERING THE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105317 MITEK UNKNOWN INTRAFIX SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention