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	10/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: during cpr the driver had a power failure while attempting to insert the io in the left tibia with a 45mm needle.The drill sounded charged and had a green light 2 days prior.
Additional Manufacturer Narrative
(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: during cpr the driver had a power failure while attempting to insert the io in the left tibia with a 45mm needle.The drill sounded charged and had a green light 2 days prior.
Additional Manufacturer Narrative
Qn#(b)(4).The manufacturing device history file was reviewed based on the potential sn number revealed from sales history.No recorded results of manufacturing issues or anomalies were reported and passed all the release criteria.The device was released in 08/2022 and is approximately 0.5 years old.Two ifus will be referenced for this investigation.The ez-io driver ifu (8048a) 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 (8087a) states, "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." corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without a sample.The complaint could not be confirmed as no sample was returned for analysis.A device history record review was performed based on a potential serial number from sales history, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Reported issue: during cpr the driver had a power failure while attempting to insert the io in the left tibia with a 45mm needle.The drill sounded charged and had a green light 2 days prior.
Additional Manufacturer Narrative
(b)(4).Ez-io driver 9058 (sn (b)(6)) was returned for evaluation.Upon receipt, the driver was visually inspected.When the trigger was pulled, the driver was operable and a solid green led light was displaying.The driver was then subjected to simulated sawbone 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/ft^3) and hard (102 lbs/ft^3) 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 successfully negotiated both the medium and hard saw bone insertion testing.The complaint cannot be confirmed.The driver was opened to test and record operating characteristics.Battery voltage measured as 17.84 dc volts without being activated.Battery voltage measured as 14.94 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 3,522,929and the cycle count was 489.The cycle count of 489 (trigger activations) is significant as it substantiates driver usage with considerations to bone density, average insertion time, storage, and frequency of testing.The eeprom results confirm that the battery is not depleted as the charge count has not exceeded the maximum depletion value of 15,300,000 per ver0190 accel biotech firmware verification test report.Additionally, 2 stall conditions were recorded.The ez-io needle ifu states, "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." testing confirms that there was no fault found with the returned driver.A copy of the manufacturing dhr file was reviewed.No recorded results of manufacturing issues or anomalies were reported.Two ifus w ill 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".The ez-io needle ifu states, "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 05/2017 and is approximately 6 years old.The complaint cannot be confirmed.Functional testing has confirmed no fault found with this driver.No corrective/preventative actions will be assigned.The complaint cannot be confirmed.Functional testing revealed no fault found with this driver as the device was able to negotiate both the medium and hard saw bones during insertion testing.No defects or anomalies were observed with the returned driver.The eeprom results confirm that the battery is not depleted as the charge count has not exceeded the maximum depletion value of 15,300,000 per accel biotech firmware verification test report.Additionally, 2 stall conditions were recorded.The ez-io needle ifu states, "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 device history record review was performed and no recorded results of manufacturing issues or anomalies were reported.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; 4 kamunting industrial estate; morrisville NC 27560
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16497411
• Report Number: 8040412-2023-00100
• Device Sequence Number: 6240036
• Product Code: FMI
• UDI-Device Identifier: 10816000013813
• UDI-Public: 10816000013813
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 03/22/2023; 04/20/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/27/2023; 04/20/2023
• 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; NONE REPORTED
• Patient Sex: Unknown