MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL; ADMIRAL ACP SCREWDRIVER (STAB AND GRAB)

Model Number	AP2-100001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was returned and visually inspected to confirm the failure mode outlined in the description of the complaint.The threads were twisted in the counterclockwise direction with evidence that approximately 1.0-1.1mm of the tip had sheared off.The root cause could not be definitively determined.It is possible that the driver experienced larger than expected torsional resistance while placing the final screw due to factors in the bony anatomy or screw trajectory.Intraoperative warnings.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) 2026, orthofix was made aware of the following event utilizing the seaspine admiral acp system.Per the reporter, the tip of the screwdriver fractured off while trying to place the last screw.The fractured piece remained in the screw and could not be removed.The screw was tamped down and the locking mechanism on the plate secured.No patient injury was reported.

• Brand Name: ADMIRAL
• Common Device Name: ADMIRAL ACP SCREWDRIVER (STAB AND GRAB)
• 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 24634242
• Report Number: 3012120772-2026-00009
• Device Sequence Number: 8596574
• Product Code: LXH
• UDI-Device Identifier: 10889981276768
• UDI-Public: 10889981276768
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: AP2-100001
• Device Catalogue Number: AP2-100001
• Device Lot Number: CR60951B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• 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