MAUDE Adverse Event Report: SEASPINE INC. ADMIRAL ACP SYSTEM; SCREWDRIVER, THREADED

Model Number	AP2-000002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Seaspine was made aware of this event on 4 may 2021.The drivers were received for analysis, and visual inspection confirmed damage to the tips.Functional torque testing of similar screws and screwdrivers made from the same material and material condition was conducted.During this test, no driver failed, although wear was noted.While the recorded user applied loads remained under the screwdriver ultimate torque, driver wear was noted when the driver was cyclically loaded to high torque values.Therefore, root cause is not determined but may be due to cyclic loading followed by a high torque application.Review of labeling: possible adverse events: bending, disassembly or fracture of implant and components.
Event or Problem Description
The patient underwent spinal surgery consisting of seaspine's admiral acp system on (b)(6) 2021.During the surgery, the ap2-000002 screwdriver, threaded tip broke, and a fragment remained in the screw head.A second ap2-000002 screwdriver, threaded was provided, and this instrument also broke in a similar manner, also leaving a fragment in a screw head (reference #3012120772-2021-00048).The surgeon determined the fragments could remain in the screw heads, as the fragments were below the head surface, and the locking cover placed over the screw further mitigated the risk of migration.The surgery was completed successfully.

• Brand Name: ADMIRAL ACP SYSTEM
• Common Device Name: SCREWDRIVER, THREADED
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 11935341
• Report Number: 3012120772-2021-00047
• Device Sequence Number: 3182018
• Product Code: KWQ
• UDI-Device Identifier: 10889981239190
• UDI-Public: 10889981239190
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: AP2-000002
• Device Catalogue Number: AP2-000002
• Device Lot Number: CR42755B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1