BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE

    MDR report key: 2472940 · Received February 16, 2012

    Report

    Report Number
    3004608878-2012-00030
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 16, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    EIL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A TOTAL WRIST FUSION SURGERY PROCEDURE USING THE INTEGRA TOTAL WRIST FUSION SYSTEM INSTRUMENTATION SET, THE SURGEON COULD NOT READ THE MARKINGS ON THE DEPTH GAUGE, EVEN USING LOUPES. SEVERAL SCREWS HAD TO BE REMOVED BECAUSE THE SURGEON WAS LEFT TO ESTIMATE THE LENGTH OF THE SCREWS, TAKE RADIOGRAPHS AND THEN ESTIMATE THE ADJUSTED REQUIRED SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPTH GAUGE WRIST FUSION INSTRUMENTS EIL INTEGRA LIFESCIENCES CORPORATION OH/USA WRISTFUSE 10 TRAY LOT NUMBER

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention