BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALIX 5.5MM BR ANCHOR

    MDR report key: 2113785 · Received June 2, 2011

    Report

    Report Number
    1221934-2011-00225
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE IS APPROXIMATELY 60 DAYS OLD: NOTHING IS BEING RETURNED, DEVICE DISCARDED, AND 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 ADDRESS WHY THE SURGEON CHOSE TO GO FROM ARTHROSCOPIC TO OPEN FOR REMEDY. WE CANNOT TELL ANYTHING FROM THIS; WE CANNOT DISCERN THE ROOT OR UNDERLYING CAUSE FOR THE REPORTED EVENT. 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 TO US THAT THE PATIENT WAS UNDERGOING AN ARTHROSCOPIC SHOULDER REPAIR WITH THE USE OF A HEALIX BR FOR FIXATION. THE MOST PROXIMAL THREAD OF THE ANCHOR BROKE OFF DURING INSERTION. AT THIS POINT, FOR WHATEVER REASON, THE SURGEON RESORTED TO AN OPEN PROCEDURE; REMOVED THE BR ANCHOR AND USED A FASTIN-RC TO FIXATE AND REPAIR. THE REPAIR WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE SURGEON IS FAMILIAR WITH HEALIX BR AND HAS BEEN USING THEM SUCCESSFULLY FOR APPROXIMATELY 3 YEARS. COMPLAINT DEVICE DISCARDED AT USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALIX 5.5MM BR ANCHOR SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 222233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention