BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 16448496 · Received February 27, 2023

    Report

    Report Number
    3011137372-2023-00020
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 1, 2023
    Report Date
    February 1, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    UDI-DI
    10816000013813
    PMA / PMN Number
    K180395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    (B)(4). EZ-IO DRIVER 9058 WAS RETURNED FOR EVALUATION. UPON RECEIPT, THE DRIVER WAS VISUALLY INSPECTED. WHEN THE TRIGGER WAS PULLED THE DRIVER WAS OPERABLE AND A BLINKING RED LED LIGHT WAS DISPLAYING. THE DRIVER WAS THEN SUBJECTED TO SIMULATED SAWBONE INSERTIONS PER DRIVER IFU. THE DRIVER EXPERIENCED A COMPLETE STALL DURING THE FIRST ATTEMPT IN THE MEDIUM SAWBONE TESTING AT 2.97 SECONDS. THE COMPLAINT HAS BEEN CONFIRMED. THE DRIVER WAS OPENED TO TEST AND RECORD OPERATING CHARACTERISTICS. BATTERY VOLTAGE MEASURED AT 18.16 DC VOLTS WITHOUT BEING ACTIVATED. THE MEASURED VOLTAGE IS SLIGHTLY LOWER THAN THE NOMINAL SPECIFICATION OF 18.2V FOR THE BATTERY PACK UPON RELEASE. THIS IS EXPECTED AFTER DEVICE USE. THE EEPROM WAS PARSED, AND THE RESULTS REVEAL THE CHARGE COUNT WAS (B)(4) AND THE CYCLE COUNT WAS (B)(4) . THE RECORDED CHARGE COUNT SUPPORTS A DEPLETED BATTERY AS THE CHARGE COUNT EXCEEDED THE MAXIMUM DEPLETION VALUE OF (B)(4) PER VER0190 ACCEL BIOTECH FIRMWARE VERIFICATION TEST REPORT. THE CYCLE COUNT OF (B)(4) (TRIGGER ACTIVATIONS) IS SIGNIFICANT AS IT SUBSTANTIATES DRIVER USAGE WITH CONSIDERATIONS TO BONE DENSITY, AVERAGE INSERTION TIME, STORAGE, AND FREQUENCY OF TESTING. THE LED WAS FURTHER EXAMINED PER THE CUSTOMER REPORT. THE LED WAS PROPERLY FUNCTIONING AS IT ILLUMINATED A BLINKING RED LED STATUS ONCE THE TRIGGER WAS ENGAGED. A COPY OF THE MANUFACTURING DEVICE HISTORY RECORD FILE WAS REVIEWED. NO RECORDED RESULTS OF MANUFACTURING ISSUES OR ANOMALIES WERE REPORTED. THE DRIVER WAS FOUND TO BE USED BEYOND ITS SHELF LIFE. IN-SERVICE CI-0000343 HAS BEEN REQUESTED. NO OTHER CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. THE COMPLAINT IS CONFIRMED SINCE THE DEVICE WAS UNABLE TO PASS FUNCTIONAL TESTING. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE DRIVER IS GREATER THAN 10 YEARS OLD. THE IFU STATES, "THE D RIVER AND ITS BATTERY HAVE A SHELF LIFE OF 10 YEARS." IT IS NOT RECOMMENDED THAT A DRIVER BE USED PASSED ITS SHELF LIFE. BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THAT USING THE DRIVER BEYOND ITS SHELF LIFE RESULTED IN THIS COMPLAINT EVENT. IN-SERVICE CI-0000343 HAS BEEN REQUESTED. NO OTHER CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED AS USER ERROR LIKELY EITHER CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    REPORTED ISSUE: ALTHOUGH THE LED CONTROL LAMP LIGHTS UP GREEN, THE NEEDLE COULD NOT BE DRILLED INTO THE BONE. THE GREEN LED WENT OUT. STATUS RED FLASHING LED DID NOT APPEAR.

    Description of Event or Problem · 0

    REPORTED ISSUE: ALTHOUGH THE LED CONTROL LAMP LIGHTS UP GREEN, THE NEEDLE COULD NOT BE DRILLED INTO THE BONE. THE GREEN LED WENT OUT. STATUS RED FLASHING LED DID NOT APPEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856112 EZ-IO POWER DRIVER NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL IPN915667 10816000013813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NONE REPORTED| NONE REPORTED