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

Model Number	T17652
Medical Device Problem Codes	Unstable (1667); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an unknown patient procedure that the reamer is pulling out of the chuck.The fitting is worn and no longer coupled well in the chuck.It wobbles as the connection is stripping.It was not used for the procedure as another device was available.There was a 30 second surgical delay, but no consequences or impact to patient.
Additional Manufacturer Narrative
The complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.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 11 years of use.The viant risk management files were reviewed to ensure the reported failure mode (or similar) is captured and assessed.The review revealed there are similar failure modes identified and mitigated to the lowest possible risk region.In conclusion, the complaint sample was not received by viant for evaluation and the reported event is non-verifiable.If the complaint sample is received by viant, it will be evaluated and the complaint record will be updated accordingly.No further investigation with regard to this complaint is required at this time.Viant will continue to monitor for trends.D4: primary udi # provided is the current viant medical udi-di for model number t17652.The additional udi # provided is the legacy greatbatch medical udi-di for model number t17652 prior to viant medical acquisition of the product.This lot number was manufactured in 2013 by greatbatch medical.Viant medical acquired this product line from greatbatch medical (subsidiary of integer holdings) in 2018.Therefore, the legacy udi-di # is provided as the additional udi # and the current udi-di # is provided as the primary udi #.G2: complaint information provided by distributor, depuy synthes.Complaint source is foreign as the event occurred in canada.

• Brand Name: VIANT MEDICAL, LLC
• Common Device Name: 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: 21326791
• Report Number: 3004976965-2025-00001
• Device Sequence Number: 8062813
• Product Code: LXH
• UDI-Device Identifier: 00840096400076
• UDI-Public: 00840096400076
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 01/07/2025

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: T17652
• Device Catalogue Number: T17652
• Device Lot Number: PC2595789
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2013
• 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