BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOTACK SUTURE ANCHOR 1.4MM

    MDR report key: 3020929 · Received March 19, 2013

    Report

    Report Number
    3007210693-2013-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 15, 2013
    Manufacturer
    PIVOT MEDICAL
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SUTURE ANCHOR REMAINS IMPLANTED, THEREFORE, IT WILL NOT BE RETURNED FOR EVAL. THIS WAS DETERMINED TO BE A REPORTABLE EVENT DUE TO THE PERMANENT NATURE OF THE SUTURE THAT WAS LEFT IN THE PT, EVEN THOUGH NO INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE SURGEON ALLEGEDLY USED A PIVOT MEDICAL NANOTACK SUTURE ANCHOR TO REATTACH THE HIP LABRUM TO THE ACETABULUM. THE SURGEON REPORTED THAT THE #1 SUTURE WAS NOT ATTACHED TO THE ANCHOR FOLLOWING DEPLOYMENT OF THE ANCHOR. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113449 NANOTACK SUTURE ANCHOR 1.4MM BONE ANCHOR MBI PIVOT MEDICAL 12121801

    Patients

    Seq Age Sex Outcome Treatment
    1