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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 25 feb 2026, orthofix was made aware of multiple admiral driver tip fractures.It was reported that the fractured tips became lodged in the screw shank and were unable to be retrieved without removing the entire screw.This resulted in a surgical delay of greater than 30 minutes.No patient injuries were reported.Quality compliance made multiple attempts to obtain further information regarding the event, however, customer was unresponsive.It is unknown if the entire screw was replaced or if the screw was left in-situ with the unretrieved fragment.This report is for 4 of 4 units.
Additional Manufacturer Narrative
The returned driver was visually inspected to confirm the failure mode outlined in the complaint description.The driver's tip was twisted and but not sheared off.The root cause could not be definitively determined.

• 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 24682864
• Report Number: 3012120772-2026-00016
• Device Sequence Number: 10042173
• Product Code: KWQ
• UDI-Device Identifier: 10889981276775
• UDI-Public: 10889981276775
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: BT113983GR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown