MAUDE Adverse Event Report: VIANT MEDICAL, LLC VIANT MEDICAL, LLC; EZ CLEAN¿ STRAIGHT REAMER HANDLE

Model Number	T5326
Medical Device Problem Codes	Unstable (1667); Material Deformation (2976); Material Twisted/Bent (2981); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: on (b)(6) 2024, viant medical became aware of a group of complaints from the customer (distributor) which viant were not made aware of.Viant is in process of coordinating with the customer to recover the devices or images for full evaluation, if still available.Once all the information is collected and evaluated by viant, a follow-up medwatch 3500a emdr will be submitted.G2: complaint information provided by distributor, enovis.
Event or Problem Description
It was reported during an unknown procedure on a 67 year old patient that while reaming the shaft started to wobble because the connection at the gun bent.The surgery was completed as intended with no delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.No consequences or impact to patient.
Additional Manufacturer Narrative
H2: the complaint sample was not returned to viant for evaluation, however the customer did perform investigation activities and have provided the findings to viant.The customer investigation details stated the following; "the instrument was returned to djo and after further examination, the tip of the reamer is bent." "the root cause of this complaint is likely attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction, or issue." the customer provided photos to viant for review and confirms the power adaptor is bent.The stryker/zimmer-hall power adaptor end was observed to be bent out of place and damaged from prolonged repeated use.Bending of this nature would not occur during normal intended use and likely would had occurred from applying non-linear load (off-axis force applied).This failure can contribute to the experienced wobble / eccentric motion.Thus, the complaint sample had been misused.It is unknown what adaptor or power source (neither provided by viant) was connected to the device.The current ifu sent with this device today, man-004006 rev.A, states the following; · end of life is determined by wear and damage due to intended use, · visually inspect for damage and wear.If the instrument is damaged and worn it is considered at the end of its life and should be discarded, · where instruments form part of a larger assembly, check assembly with mating components, · viant devices should only be used by qualified personnel fully trained in the use of the surgical instruments and the relevant surgical procedures, · do not modify viant instruments in any way and handle with care at all times.Surface scratches can increase wear and the risk of corrosion, · manual surgical instruments have a limited life-span which is determined by wear or damage due to repeated intended use.When a surgical instrument reaches the end of its functional life, clean the instrument of any and all biomaterial/biohazards and safely discard the instrument in accordance with applicable laws and regulations.The device history records (dhr) were reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.This device has experienced approximately 5.48 years of use.It is unknown how many surgical procedures (cycles) this device has experienced throughout its life in the field.The viant risk management files were reviewed and the failure modes were identified and mitigated to the lowest possible level.A trend analysis was performed and similar complaints were attributed to misuse (off-axis force).The trend analysis reveals the estimated failure rate falls within the occurrence range identified in the viant risk management files.In conclusion, the reported event is confirmed as the returned straight reamer handle power adaptor is bent leading to the reported wobble / eccentric motion.From the investigation performed, the root cause attributed to the reported event is misuse (unintended use) as bending of this nature would not occur during normal intended use and likely would had occurred from applying non-linear load (off-axis force applied).No further investigation with regard to this complaint is required at this time.Viant will continue to monitor for trends.H2,d1,d2b,d4: corrected brand name, common device name, model number, and catalog number.H6: updated type of investigation, investigation findings, & conclusions.
Additional Manufacturer Narrative
H3: the customer provided photos and the returned complaint sample confirms the power adaptor is bent.The stryker/zimmer-hall power adaptor end was observed to be bent out of place and damaged from prolonged repeated use.Bending of this nature would not occur during normal intended use and likely would had occurred from applying non-linear load (off-axis force applied).This failure can contribute to the experienced wobble / eccentric motion.Thus, the complaint sample had been misused.It is unknown what adaptor or power source (neither provided by viant) was connected to the device.The current ifu sent with this device today, man-004006 rev.A, states the following; · end of life is determined by wear and damage due to intended use, · visually inspect for damage and wear.If the instrument is damaged and worn it is considered at the end of its life and should be discarded, · where instruments form part of a larger assembly, check assembly with mating components, · viant devices should only be used by qualified personnel fully trained in the use of the surgical instruments and the relevant surgical procedures, · do not modify viant instruments in any way and handle with care at all times.Surface scratches can increase wear and the risk of corrosion, · manual surgical instruments have a limited life-span which is determined by wear or damage due to repeated intended use.When a surgical instrument reaches the end of its functional life, clean the instrument of any and all biomaterial/biohazards and safely discard the instrument in accordance with applicable laws and regulations.The device history records (dhr) were reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.This device has experienced approximately 5.48 years of use.It is unknown how many surgical procedures (cycles) this device has experienced throughout its life in the field.The viant risk management files were reviewed and the failure modes were identified and mitigated to the lowest possible level.A trend analysis was performed and similar complaints were attributed to misuse (off-axis force).The trend analysis reveals the estimated failure rate falls within the occurrence range identified in the viant risk management files.In conclusion, the reported event is confirmed as the returned straight reamer handle power adaptor is bent leading to the reported wobble / eccentric motion.From the investigation performed, the root cause attributed to the reported event is misuse (unintended use) as bending of this nature would not occur during normal intended use and likely would had occurred from applying non-linear load (off-axis force applied).No further investigation with regard to this complaint is required at this time.Viant will continue to monitor for trends.D9,g3,h2: added date returned to manufacturer.H2,h11: device evaluation updated.H6: updated type of investigation.

• Brand Name: VIANT MEDICAL, LLC
• Common Device Name: EZ CLEAN¿ STRAIGHT REAMER HANDLE
• Manufacturer (Section D): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne IN 46818
• Manufacturer (Section G): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne IN 46818
• Manufacturer Contact: tony singh ; 4545 kroemer road; fort wayne, IN 46818
• MDR Report Key: 20218754
• Report Number: 3004976965-2024-00018
• Device Sequence Number: 20765149
• Product Code: LXH
• UDI-Device Identifier: 00840096401400
• UDI-Public: 00840096401400
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2024

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
• Device Model Number: T5326
• Device Catalogue Number: 803-05-198
• Device Lot Number: 4313225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 11/11/2024
• Initial Report FDA Received Date: 09/14/2024
• Supplement Report FDA Received Date: 10/14/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Unknown