MAUDE Adverse Event Report: WELLS JOHNSON CO. MULTI HOLE 6; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	20121800
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	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a liposuction procedure, the cannula shaft detached from the base.The procedure was completed using an alternate cannula, and there were no reported injuries or procedural delays.The device was returned for evaluation.Visual inspection confirmed that the cannula shaft was bent and had separated from the base.The solder joint was fractured, and a dent was observed in the stainless-steel hub, indicating mechanical stress.A review of the device history record confirmed the product met all manufacturing specifications and passed inspection with no nonconformities or deviations noted.The instructions for use (mkt-2901 rev.01) for cannulas advises against bending or applying excessive force to the device, as these actions may compromise structural integrity.The totality of the evidence indicates that the device was manufactured according to specifications and that no manufacturing deficiencies were identified.The observed damage is consistent with mechanical force applied by the user and is attributed to handling or use that deviates from the conditions described in the instructions for use.This incident is considered isolated, as no other complaints involving this specific type of failure have been reported for this device type in the past five years.

• Brand Name: MULTI HOLE 6
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): WELLS JOHNSON CO.; 8000 south kolb road; tucson AZ 85756
• Manufacturer Contact: bryan rusnak ; 8000 south kolb road; tucson, AZ 85756 ; 5202986069
• MDR Report Key: 22497544
• Report Number: 2024022-2025-00003
• Device Sequence Number: 15203669
• Product Code: GEA
• UDI-Device Identifier: B458201218000
• UDI-Public: +B458201218000/
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 20121800
• Device Catalogue Number: 20-1218-00
• Device Lot Number: 0124807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown