BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VERSALOK TI ANCHOR

    MDR report key: 2192712 · Received August 5, 2011

    Report

    Report Number
    1221934-2011-00291
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K063478
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    NOTHING IS BEING RETURNED FOR EVALUATION: COMPLAINT DEVICE DISCARDED AT USER FACILITY. 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 COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT TELL ANYTHING FROM THIS; WE CANNOT DISCERN THE ROOT OR UNDERLYING CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE AND CLARIFYING 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 THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE SLEEVE OF THE VERSALOK ANCHOR BROKE AWAY DURING DEPLOYMENT AND FELL INTO THE JOINT SPACE. THE 'SLEEVE' WAS EASILY RETRIEVED FROM THE BODY. ALTHOUGH THE SURGEON HAD INTENDED TO DO A DOUBLE ROW REPAIR, THE SURGEON CONCLUDED THE PROCEDURE WITH A SINGLE ROW AND WAS SATISFIED WITH A SUCCESSFUL REPAIR. THERE WERE NO FURTHER ISSUE OR HARM TO THE PATIENT. NOTHING BEING RETURNED FOR EVALUATION, THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VERSALOK TI ANCHOR SOFT TISSUE FIXATION DEVICE HWC DEPUY MITEK NA 3470258

    Patients

    Seq Age Sex Outcome Treatment
    1