BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SST FIBULA NAIL

    MDR report key: 1173483 · Received September 25, 2008

    Report

    Report Number
    2242816-2008-00132
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    November 29, 2007
    Report Date
    September 24, 2008
    Manufacturer
    EBI, LLC
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DHR FOR THE RELATED LOT SHOWED THAT THE THREAD FORM WAS INSPECTED AT 100% AND MET REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. INVESTIGATION OF THE RETURNED DEVICE DETERMINED THAT THE THREAD FORM IS NO LONGER WITHIN SPECIFICATION. THE REMAINDER OF THE DIMENSIONS WERE WITHIN SPECIFICATION. SAMPLES FROM EXISTING INVENTORY WAS DETERMINED TO BE WITHIN SPECIFICATION. NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. THIS MDR IS A RESULT OF A RETROSPECTIVE REVIEW OF THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVER BOLT WAS NOT ABLE TO THREAD INTO THE FIBULA NAIL. AN ADDITIONAL NAIL WAS USED AND THE BOLT WAS ABLE TO THREAD AS INTENDED. PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SST FIBULA NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB EBI, LLC 430560

    Patients

    Seq Age Sex Outcome Treatment
    1