MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MERIDIAN; STRAIGHT DRIVER

Model Number	RA2-003020
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ra2-003020 straight driver was returned and evaluated.It was observed that the tip of the driver had sheared off during use, which confirms the reported failure.It was also observed the hexalobe driver feature of the instrument was twisted/deformed.The root cause for this failure mode is likely from excessive force applied during screw placement, which led to the tip fracture.Review of labeling: intraoperative warnings, consult the surgical technique guide for system specific intraoperative warnings, precautions, and recommendations.Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
Event or Problem Description
On (b)(6) 2025, a surgeon experienced issues when using the meridian straight driver.When implanting a screw, the tip of the meridian straight driver fractured off.Although the surgeon attempted to retrieve the tip from the screw head, it was unable to be removed and the screw remained implanted with the fractured tip inside.No patient injuries were reported and no additional medical or surgical treatment was required.Additionally, the rep confirmed the issue did not cause a delay in the surgical procedure.The surgery was able to be completed with a back-up meridian straight driver.

• Brand Name: MERIDIAN
• Common Device Name: STRAIGHT DRIVER
• 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: 23832707
• Report Number: 3012120772-2025-00069
• Device Sequence Number: 20107220
• Product Code: LXH
• UDI-Device Identifier: 10889981216405
• UDI-Public: 10889981216405
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: RA2-003020
• Device Catalogue Number: RA2-003020
• Device Lot Number: CR50728D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2023
• 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