MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL; ADMIRAL ACP SCREWDRIVER, THREADED

Model Number	AP2-100002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 03 apr 2026, orthofix was made aware of the following event utilizing the seaspine admiral acp system.Per the reporter, the tip of the screwdriver sheared off and became stuck in the screw.The fractured tip remained in the screw and could not be removed.They could only partially slide the locking cover over the screws.The patient was reported to be uninjured.
Additional Manufacturer Narrative
H3: instrument has been returned, but outcome of the investigation is still pending.Intraoperative warnings: breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.

• Brand Name: ADMIRAL
• Common Device Name: ADMIRAL ACP SCREWDRIVER, THREADED
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 25058661
• Report Number: 3012120772-2026-00026
• Device Sequence Number: 21188886
• Product Code: KWQ
• UDI-Device Identifier: 10889981276775
• UDI-Public: 10889981276775
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K212139
• 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,Followup
• Report Date (Section B): 06/02/2026

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: AP2-100002
• Device Catalogue Number: AP2-100002
• Device Lot Number: BT073453C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown