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

Model Number	T2756
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2026
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, (b)(4).Complaint source is foreign as event occurred in canada.
Event or Problem Description
It was reported during an unknown patient procedure that while reaming the acetabulum the reamer shaft wasn't stable and was wobbling.No consequences or impact to patient.

• 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: 24913768
• Report Number: 3004976965-2026-00008
• Device Sequence Number: 9102643
• Product Code: LXH
• UDI-Device Identifier: 00840096401394
• UDI-Public: 00840096401394
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 06/12/2026

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: 5185625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 05/15/2026; 05/15/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/15/2026; 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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