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

Model Number	AP2-100002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The admiral acp screwdriver is not available for evaluation.No definitive root cause could be established.Review of labeling: possible adverse events.Bending, disassembly, or fracture of implant and components.
Event or Problem Description
Customer reports that during a surgery that took place on (b)(6) 2025, the tip of the ap2-100002 admiral acp screwdriver sheared off.All pieces were retrieved; however, the issue resulted in a 30-minute surgical delay.No additional medical or surgical treatment was required; the surgery was able to be completed and there were no adverse patient outcomes.Customer states the surgeon used the proper technique with the instrumentation.Multiple follow-up attempts were performed to have the product returned for investigation, however, the admiral acp screwdrivers were not returned and are not available for evaluation.This occurred with two separate admiral acp screwdrivers.This mdr is to document the event against one lot of the admiral acp screwdrivers.See mdr 3012120772-2025-00031 for the second lot.

• Brand Name: ADMIRAL
• Common Device Name: ADMIRAL ACP SCREWDRIVER, THREADED
• 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: 22007055
• Report Number: 3012120772-2025-00030
• Device Sequence Number: 5355901
• Product Code: KWQ
• UDI-Device Identifier: 10889981276775
• UDI-Public: 10889981276775
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K212139
• 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): 05/12/2025

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: AP2-100002
• Device Catalogue Number: AP2-100002
• Device Lot Number: BT100539E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown