MAUDE Adverse Event Report: TENEX HEALTH, INC. TX SYSTEM - TX1 MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	554-1003-001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported pain and observed a retained portion of the microtip needle emerging from their foot 4-6 weeks following a procedure with the tenex system (approximately between (b)(6) 2025).Patient extracted the needle under direction from their doctor and is expected to follow up with the doctor.
Additional Manufacturer Narrative
The device was not returned for evaluation.Pictures of the removed needle fragment were provided by the reporter.It was confirmed that the microtip needle had separated from the rest of the handpiece.The fracture site did not immediately indicate a specific cause for the failure.

• Brand Name: TX SYSTEM - TX1 MICROTIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• Manufacturer (Section G): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• Manufacturer Contact: david vancelette ; 26902 vista terrace; lake forest, CA 92630-8123 ; 9492388220
• MDR Report Key: 23297041
• Report Number: 1000135560-2025-00036
• Device Sequence Number: 18690379
• Product Code: LFL
• UDI-Device Identifier: 00857156006215
• UDI-Public: (01)00857156006215
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 554-1003-001
• Device Catalogue Number: 554-1003-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown