MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION REGATTA; EASY CONNECT T-HANDLE

Model Number	36-90-3018
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the 36-90-3018 easy connect t-handle was not returned for evaluation.Although multiple attempts were made to obtain further information from the distributor rep regarding the return, no additional detail was provided.The root cause cannot be determined as the product was not provided for evaluation.
Event or Problem Description
On (b)(6) 2025, a surgeon experienced issues when using the regatta easy connect t-handle.While impacting, the regatta easy connect t-handle became jammed and was unable to be released.The surgery was able to be completed successfully utilizing an alternate seaspine instrument (mariner handle), however, the issue led to approximately a half hour delay in the surgical procedure, prompting this report.No patient injuries were reported and the problem did not require additional medical or surgical treatment.

• Brand Name: REGATTA
• Common Device Name: EASY CONNECT T-HANDLE
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: danielle nelson-archer ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 23839463
• Report Number: 3012120772-2025-00070
• Device Sequence Number: 9571500
• Product Code: LXH
• UDI-Device Identifier: 10889981171971
• UDI-Public: 10889981171971
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 36-90-3018
• Device Catalogue Number: 36-90-3018
• Device Lot Number: CR51278C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown