MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL; TEMPORARY FIXATION PIN

Model Number	AP2-100506
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports that during a surgery that took place on (b)(6) 2025, an admiral temporary fixation pin broke with the distal portion of the pin remaining in the bone.There was no way to retrieve the piece that remained in the bone; however, the surgeon did not feel there was any risk of that portion backing out of the bone.There was no clinically significant delay in surgery and no patient injury reported.The admiral temporary fixation pin was not saved by the customer due to the size and sharpness, therefore, the product is not available for evaluation.Additionally, the customer states the lot number was not legible as the laser marking was no longer dark and was incredibly small.
Additional Manufacturer Narrative
The product is not available for evaluation; no lot information was provided.No definitive root cause could be established.Review of labeling: possible adverse events, - bending, disassembly, or fracture of implant and components.- intraoperative fissure, fracture, or perforation of the spine.

• Brand Name: ADMIRAL
• Common Device Name: TEMPORARY FIXATION PIN
• 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: 21554470
• Report Number: 3012120772-2025-00009
• Device Sequence Number: 18183924
• Product Code: KWQ
• UDI-Device Identifier: 10889981277109
• UDI-Public: 10889981277109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/07/2025

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: AP2-100506
• Device Catalogue Number: AP2-100506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown