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

Model Number	T17653
Medical Device Problem Codes	Break (1069); Unstable (1667); Material Integrity Problem (2978); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
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, check hinged instruments for smooth movement, each component of the viant offset reamer handle is not a medical device, all components when assembled create the medical device.Therefore, the components of each viant reamer handle form a unique set when assembled.In no instance should the components from one offset reamer handle be mixed with components from another reamer handle.The unique device identification for this medical device is located on the assembled offset reamer handle, 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 record (dhr) review was not performed as the lot number is unknown.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.D9, h3: the distributor stated that all broken pieces were accounted for, removed from the field, and disposed of.The device will not be returned for evaluation.G2: complaint information provided by distributor, depuy synthes.
Event or Problem Description
It was reported during an unknown patient procedure that while reaming acetabulum the surgeon noticed that the reamer was not reaming symmetrically.The reamer handle was taken apart and the inner shaft of the reamer was broken.All broken pieces were accounted for, removed from the field, and disposed of.There was 5 minute surgical delay in surgery while staff got another tray.No consequences or impact to patient.

• Brand Name: VIANT MEDICAL, LLC
• Common Device Name: OFFSET 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: 21585594
• Report Number: 3004976965-2025-00003
• Device Sequence Number: 21199209
• Product Code: LXH
• UDI-Device Identifier: 00840096400083
• UDI-Public: 00840096400083
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

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: T17653
• Device Catalogue Number: T17653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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