BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INBONE(R) PROPHECY C-BRACKET

    MDR report key: 5111029 · Received September 29, 2015

    Report

    Report Number
    1043534-2015-00075
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    June 10, 2015
    Report Date
    September 29, 2015
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT COMPLETE. PRODUCT HAS NOT BEEN RETURNED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PARTS FOUND THAT THE TURNING KNOB IS STUCK (NOT TURNING) IN C-BRACKET MOVING ARM. OTHER THAN THAT THERE WAS NO OTHER UNUSUAL DAMAGE OBSERVED. ANALYSIS OF THE RETURNED DEVICES INDICATES THAT THE DEVICE WAS A CONTRIBUTOR TO THE REPORTED EVENT. BASED ON ANALYSIS, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER THE MOST LIKELY ROOT CAUSE WAS DUE TO CROSS THREADING IN THE ALUMINUM C-BRACKET MOVING ARM CAUSED BY EXTERNAL STRESSES APPLIED TO THE SCREW. THE PART WAS IN USE ALMOST 4 YEARS AND THE AGE IS THE CONTRIBUTOR TO THE ISSUE.

    Description of Event or Problem · 1

    ALLEGEDLY, THE KNOB USED TO TIGHTEN THE PROPHECY FOOT HOLDER ON THE SLIDING RAILS WAS STRIPPED AND THE PHYSICIAN WAS UNABLE TO LOOSEN IT, WHICH ADDED 30 MINUTES TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642858 INBONE(R) PROPHECY C-BRACKET SMALL JOINT INSTRUMENT HSN WRIGHT MEDICAL TECHNOLOGY, INC. 945020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other