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	Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Tendon injury is referenced in the ultraguidectr instructions for use as a possible complication.No device malfunction was reported.
Event or Problem Description
The ultraguidectr primed and functioned normally during the procedure on (b)(6) 2023, and the procedure was uneventful.The physician indicated that he took multiple passes with the device to ensure a complete release, but did not note any unusual difficulty cutting the ligament.The patient tolerated the procedure well and the post-operative course was uneventful until 3 weeks post-procedure, when the patient heard a pop in their hand and was having difficulty normally bending the ring finger.An evaluation with diagnostic ultrasound confirmed a flexor digitorum superficialis (fds)-ring finger rupture at the level of the wrist crease.The physician explored and repaired the tendon, and the patient is recovering uneventfully.The physician did not see anything unusual at the time of the tendon repair and the patient had no other identifiable risk factors for tendon rupture.

• Brand Name: ULTRAGUIDECTR
• Common Device Name: CARPAL TUNNEL RELEASE SYSTEM
• Manufacturer (Section D): SONEX HEALTH; 950 blue gentian road #200; eagan MN 55121
• Manufacturer (Section G): SONEX HEALTH; 950 blue gentian road #200; eagan 55121
• Manufacturer Contact: sara petrie ; 950 blue gentian road #200; eagan, MN 55121
• MDR Report Key: 18588050
• Report Number: 3013479847-2024-00001
• Device Sequence Number: 20590749
• Product Code: LXH
• UDI-Device Identifier: 00860002094700
• UDI-Public: (01)00860002094700(17)UNKNOWN(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2024

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: 01/23/2024
• Initial Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown