MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL ACP SYSTEM; TRIAL DRILL GUIDE, 7MM

Model Number	AP2-100407
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional assessments of the returned drill and drill guide confirmed a deformation mid-way down one of the 15-degree barrels of the drill guide, hindering the passage in which the drill guide would pass through.This deformation suggests that the mating drill was not properly aligned with the barrel axis during the procedure, likely veering towards the patient's midline under wound pressure.This misalignment would cause interference with the barrel, potentially leading to the reported fracture.Alternatively, gradual wear over multiple uses could have contributed to the deformation of the barrel.
Event or Problem Description
On (b)(6) 2024 seaspine was made aware of a malfunction that occurred during a surgery consisting of seaspine's admiral cervical plate system.It was reported that while attempting to drill, the drill guide would not accept the drill, resulting in a 30 minute surgical delay.

• Brand Name: ADMIRAL ACP SYSTEM
• Common Device Name: TRIAL DRILL GUIDE, 7MM
• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 19274110
• Report Number: 3012120772-2024-00011
• Device Sequence Number: 15310946
• Product Code: KWQ
• UDI-Device Identifier: 10889981277000
• UDI-Public: 10889981277000
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AP2-100407
• Device Catalogue Number: AP2-100407
• Device Lot Number: TE161637G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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