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

Model Number	T17653
Medical Device Problem Codes	Vibration (1674); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an unknown patient procedure that the device is wobbling in the drill chuck.No consequences or impact to patient.
Additional Manufacturer Narrative
The complaint sample was not returned to viant for evaluation but the customer provided an image.However, the provided image is insufficient to verify the reported failure.Thus, the reported event is non-verifiable.The customer provided image shows only the index handle tube of the offset reamer handle assembly with the product identifiers.The drive chain and both z-tubes of the offset reamer handle assembly is not visible.There is no obvious failure or damage observed that would contribute to the reported failure based on this image.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 found no related manufacturing deviations or anomalies that would have contributed to the reported event.Chain assembly operation 800 (final inspection) function tested at 100% frequency and all 48 units passed.Offset reamer handle assembly operation 800 (final inspection) function, assembly, visual inspection per offset reamer handle work instructions at 100% frequency and all 48 units passed.Finished offset reamer handle operation 60 (assembly) & 800 (final inspection) function tested to actuate device, must spin freely at 100% frequency and all 48 units passed.Based on the lot number, the device had experienced approximately 1.42 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 the failure modes were identified and mitigated to the lowest possible level.In conclusion, the reported event is non-verifiable as the provided image of the index handle tube of the offset reamer handle assembly show no obvious failure or damage that would contribute to the reported failure based on the image.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.

• Brand Name: OFFSET REAMER HANDLE
• 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: 19320402
• Report Number: 3004976965-2024-00009
• Device Sequence Number: 6358133
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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
• Operator of Device: Health Professional
• Device Model Number: T17653
• Device Catalogue Number: 255000100
• Device Lot Number: PC5470404-35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2022
• 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