MAUDE Adverse Event Report: SONEX HEALTH ULTRAGUIDECTR; CARPAL TUNNEL RELEASE SYSTEM

Model Number	600112-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Neuropathy (1983); Numbness (2415)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of the event in section b3 of this report was selected as 11/01/2025 to reflect that the event occurred in november 2025.The exact date of the event is unknown.The device was not returned for analysis.Additionally, the lot number was not reported and therefore a review of device history records could not be performed.Nerve injury is referenced in the ultraguidectr instructions for use as a possible complication.No device malfunction was reported.
Event or Problem Description
According to information obtained from the operating surgeon, a ctr-us (carpal tunnel release using ultrasound guidance) was performed in (b)(6) 2024 for severe cts (carpal tunnel syndrome), including proximally radiating pain.The procedure was uneventful with no device malfunction.Two weeks post-operatively, the cts symptoms had completely resolved.However, the patient reported new numbness in the 3rd webspace.The numbness persisted and an mri in (b)(6) 2025 demonstrated post-operative changes but no other abnormalities.The patient eventually developed some irritative symptoms (paresthesias) associated with the numbness.An exploration using an open carpal tunnel release approach was performed in (b)(6) 2025.Focal swelling (noted as a "knot") was noted, potentially indicative of a neuroma in continuity.However, there was no clear sign of injury.The physician excised the enlarged nerve segment and performed a connector assisted nerve repair.In the early post-operative period, the patient's paresthesias had already resolved, though she continued to have numbness in the third interspace.The physician plans to follow the patient and anticipates some recovery of sensation.

• Brand Name: ULTRAGUIDECTR
• Common Device Name: CARPAL TUNNEL RELEASE SYSTEM
• Manufacturer (Section D): SONEX HEALTH; 950 blue gentian road #200; eagan 55121
• Manufacturer (Section G): SONEX HEALTH; 950 blue gentian road #200; eagan 55121
• Manufacturer Contact: sara petrie ; 950 blue gentian road #200; eagan 55121
• MDR Report Key: 22643139
• Report Number: 3013479847-2025-00002
• Device Sequence Number: 18333626
• Product Code: LXH
• UDI-Device Identifier: 00860002094700
• UDI-Public: (01)00860002094700(17)UNKNOWN(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K192873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 600112-001
• 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: 07/21/2025
• Initial Report FDA Received Date: 07/29/2025
• 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: Required Intervention
• Patient Sex: Female