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

Model Number	T2756
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	05/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the customer has indicated the complaint sample will be returned to viant for evaluation but has not yet been received to date.Once the complaint sample is received, it will be investigated and a follow-up medwatch 3500a emdr will be submitted.G2: complaint information provided by distributor, zimmer biomet.Complaint source is foreign as event occurred in canada.
Event or Problem Description
It was reported that the reamer is bent at the connection and wobbles.No patient involvement.
Additional Manufacturer Narrative
H3: the complaint sample was returned incomplete to viant for evaluation and the reported event is confirmed.The straight reamer handle power adaptor is bent leading to the reported wobble.The teflon sleeve was not returned with the assembly rendering the device incomplete and unable to assemble as intended.The stryker/zimmer-hall power adaptor end was observed to be slightly bent out of place.A bent/deformed power adaptor causes a non-linear (eccentric) reaming motion of the device when connected and powered by the surgical drill.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).Thus, the complaint sample had been misused.It is unknown what adaptor or power source (neither provided by viant) was connected to the device.Damage and deformation was also observed on the slots of the reamer head component.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, check hinged instruments for smooth movement, 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.The device had experienced approximately 3.62 years of use.It is unknown as to how many surgical procedures (cycles) this device had experienced throughout its life in the field.The viant risk management files were reviewed and identified similar failure modes to the observed failure.From the trend analysis performed, the estimated failure rate falls within the occurrence rate 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.From the investigation performed, the root cause is attributed to user error (misuse) 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.Viant will continue to monitor for trends.D9,g3,h2: added date device returned to manufacturer.H6: updated component, type of investigation, investigation findings, & conclusions codes.

• Brand Name: VIANT MEDICAL, LLC
• Common Device Name: EZ CLEAN¿ 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: zaadvinder sajjan ; 4545 kroemer road; fort wayne, IN 46818
• MDR Report Key: 22136396
• Report Number: 3004976965-2025-00007
• Device Sequence Number: 7343358
• Product Code: LXH
• UDI-Device Identifier: 00840096401394
• UDI-Public: 00840096401394
• Combination Product (Y/N): N
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: T2756
• Device Catalogue Number: 00-1206-090-10
• Device Lot Number: 56596837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• 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 Sex: Unknown