BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK VERSALOK TI ANCHOR W/ORTHOCORD

    MDR report key: 3001832 · Received March 13, 2013

    Report

    Report Number
    1221934-2013-00058
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K063478
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    FIFTY-EIGHT DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK, AND TO DATE, DESPITE OUTREACHES, NO ADDITIONAL INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. NOTHING IS BEING RETURNED FOR EVALUATION; COMPLAINT DEVICE DISCARDED AT USER FACILITY. NO LOT NUMBER HAS 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. 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.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT A PATIENT UNDERWENT A SUCCESSFUL SHOULDER REPAIR WITH THE USE OF A VERSALOK ANCHOR FOR FIXATION SOMETIME IN (B)(6) 2012. AT SOME POINT IN TIME SUBSEQUENTLY, THE PATIENT PRESENTED (NOT DEFINED) AND IT WAS DETERMINED THROUGH IMAGING THAT THE VERSALOK ANCHOR HAD TO A DEGREE BACKED OUT OF THE BONE HOLE; WAS SITTING PROUD. THE PATIENT UNDERWENT A RE-SURGERY ON (B)(6) 2013 AT WHICH POINT THE SURGEON REMOVED THE ANCHOR ARTHROSCOPICALLY USING A GRASPER. NO DEVICE BEING RETURNED. THIS IS ALL OF THE INFORMATION SUPPLIED TO MITEK AT THIS TIME; THERE ARE QUESTIONS OUR FOR FURTHER DETAIL AND CLARITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106120 MITEK VERSALOK TI ANCHOR W/ORTHOCORD SOFT TISSUE FIXATION DEVICE HWC DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention