MAUDE Adverse Event Report: WELLS JOHNSON CO. C-MAX; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	20155000
Medical Device Problem Codes	Material Separation (1562); Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a clinical procedure, an infiltration cannula was reported to have separated at the shaft-to-base interface during use.The procedure was completed using an alternate cannula, and no patient injury or adverse clinical outcome occurred.The affected device was not returned to the manufacturer; therefore, the investigation was limited to review of customer provided photographs and internal manufacturing records.Review of the photographs confirmed separation of the cannula shaft from the base, with no obvious bending, deformation, or external damage visible; internal joint integrity could not be evaluated in the absence of the device.Review of the device history record confirmed that the device was manufactured in accordance with approved specifications, with all required in-process and final inspections completed and accepted and no deviations, nonconformance's, or rework documented.Based on the available information, the event is classified as an undetermined mechanical failure at the shaft-to-base interface.The reported failure mode is consistent with separation that may occur under lateral stress or excessive mechanical loading which can compromise structural integrity at the interface.No manufacturing or material defects were identified.Complaint data for similar devices will continue to be monitored for potential trends.The manufacturer will provide additional information to the fda if new or relevant findings become available.

• Brand Name: C-MAX
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): WELLS JOHNSON CO.; 8000 s kolb rd; tucson AZ 85756
• Manufacturer Contact: bryan rusnak ; 8000 s kolb rd; tucson, AZ 85756 ; 5202986069
• MDR Report Key: 24101610
• Report Number: 2024022-2026-00002
• Device Sequence Number: 16004903
• Product Code: GEA
• UDI-Device Identifier: B458201550000
• UDI-Public: +B458201550000$
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: 20155000
• Device Catalogue Number: 20-1550-00
• Device Lot Number: 0125153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown