MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO POWER DRIVER; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN915667
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: driver battery stopped working in the middle of an insertion; insertion completed by manually.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: driver battery stopped working in the middle of an insertion; insertion completed by manually.
Additional Manufacturer Narrative
(b)(4).Ez-io driver 9058 (sn (b)(6)) was returned for evaluation.Upon receipt, the driver was visually inspected.Scratches were identified on the outer casing which is indicative of normal use from the trigger guard.When the trigger was pulled the driver was operable and a blinking red led light was displaying.The driver was then subjected to simulated saw bone insertions per driver ifu.This functional test is used to determine whether the returned device still has the capability to power a 45mm ez-io needle set into a medium and/or hard bone.The 45mm ez-io needle set is used because it represents the worst case scenario for io insertion.Two (2) sawbones with medium (50 lbs/ft3) and hard (102 lbs/ft3) hardness profiles with 3mm cortexes were used for the test.Each insertion was timed with a stopwatch while applying approximately 8 lbs.Of force on a weight scale.Approximately 5 to 8 lbs.Of force is necessary to penetrate bone.The driver experienced a complete stall during the second attempt in the hard saw bone testing at 8.44 seconds.The complaint has been confirmed.The driver was opened to test and record operating characteristics.Battery voltage measured at 17.16 dc volts without being activated.Battery voltage measured as 13.20 dc volts when button was activated and voltage reached a stable level.Stable defined as when whole numbers (e.G., 6 volts, 7 volts, etc.) stop changing (ignoring numbers after the decimal point).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 16,014,710 and the cycle count was 286.The recorded charge count supports a depleted battery as the charge count exceeded the maximum depletion value of 15,300,000 per ver0190 accel biotech firmware verification test report.The cycle count of 286 (trigger activations) is significant as it substantiates driver usage with considerations to bone density, average insertion time, storage, and frequency of testing.Additionally, one stall condition was recorded.The motor/gearbox assembly were connected to dc power supply and set to approximately 18v.When the trigger was pulled the motor and gear box were operable.A blinking red led light display was still observed.Testing confirms that the failure is related to battery depletion due to normal wear.A copy of the manufacturing dhr file was reviewed.No recorded results of m anufacturing issues or anomalies were reported.Two ifus will be referenced for this investigation.The ez-io driver ifu states, "as with any emergency medical device carrying a backup is strongly advised protocol", "ez-io power driver led will blink red when the trigger is activated and has only 10% of battery life remaining", and "purchase and replace the ez-io power driver when the red led begins blinking".The ez-io needle ifu states, "important: control patient movement prior to and during procedure.Squeeze trigger and apply gentle, steady pressure.Important: do not use excessive force.Note: if ez-io power driver stalls and ez-io needle set will not penetrate the bone, operator may be applying too much downward pressure to penetrate bone." a review of the device history record found that the driver passed all the release criteria.The device was released in 04/2014 and is approximately 9 years old.The complaint has been confirmed.Per functional testing and the eeprom data analysis, the failure is the result of battery depletion due to normal wear.No corrective/preventative actions will be assigned.The complaint has been confirmed.Per functional testing and the eeprom data analysis, the failure is the result of battery depletion due to normal wear.It should be noted that the driver operated as designed.Once the battery reaches a quantified low energy level, the red blinking light will activate signaling that the driver has approximately 10% energy reserve left.The ez-io driver ifu states, "as with any emergency medical device carrying a backup is strongly advised protocol", "ez-io power driver led will blink red when the trigger is activated and has only 10% of battery life remaining", and "purchase and replace the ez-io power driver when the red led begins blinking".Additionally, the ez-io needle ifu states, "important: control patient movement prior to and during procedure.Squeeze trigger and apply gentle, steady pressure.Important: do not use excessive force.Note: if ez-io power driver stalls and ez-io needle set will not penetrate the bone, operator may be applying too much downward pressure to penetrate bone.".A review of the device history record found that the driver passed all the release criteria.Therefore, the root cause is unintentional user error - normal wear.No further action is required.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: EZ-IO POWER DRIVER
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16649093
• Report Number: 3011137372-2023-00065
• Device Sequence Number: 5491329
• Product Code: FMI
• UDI-Device Identifier: 10816000013813
• UDI-Public: 10816000013813
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN915667
• Device Catalogue Number: 9058
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown