BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK HEALIX ADVANCE BR 5.5 MM - 3 SUTURE W/ORTHCORD

    MDR report key: 3024085 · Received March 27, 2013

    Report

    Report Number
    1221934-2013-00082
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 26, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K120078
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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 REP. IS REPORTING TO US THAT A PATIENT UNDERWENT A SUCCESSFUL ARTHROSCOPIC ROTATOR CUFF REPAIR ON (B)(6) 2012 WITH THE USE OF HEALIX ADVANCE FOR FIXATION. AT SOMETIME SUBSEQUENT, THE PATIENT PRESENTED WITH PAIN; IMAGING REVEALED THAT THE CUFF WAS TORN. ON (B)(6) 2013, THE PATIENT UNDERWENT A REVISION SURGERY TO REMEDY THE ISSUE; AT THIS PROCEDURE THE SURGEON NOTED THAT THE ORIGINAL HEALIX WAS STILL SECURED IN THE BONE; HOWEVER, THE SUTURE HAD SEPARATED FROM ITS ANCHOR POINT LEAVING THE CUFF LOOSE. THE SURGEON LEFT THE ORIGINAL ANCHOR IN PLACE, AND EMPLOYED 2 HEALIX PEAK ANCHORS TO RE-FIXATE. THIS PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127046 MITEK HEALIX ADVANCE BR 5.5 MM - 3 SUTURE W/ORTHCORD SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK NA 3616011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention