MAUDE Adverse Event Report: ARTHREX, INC. CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, a patient's legal representative reported via email that the patient underwent open reduction and internal fixation of a comminuted fracture of the left humeral neck on (b)(6) 2024.Following the procedure, the patient experienced ongoing complications, including persistent pain, nonunion of the fracture, and significant discomfort with any movement of the left shoulder.On (b)(6) 2024, the patient was informed that a targeter/drill guide had been inadvertently retained from the initial procedure.A revision surgery was performed on (b)(6) 2024 to remove the retained instrument, debride the infected area, and replace the surgical hardware.Additional information received on 7/2/2025: during the revision surgery on (b)(6) 2024, the following components were removed: one 3022-005 proximal humeral plate; two 8110-032 cortical screws; two 8110-035 cortical screws; one 8110-040 cortical screw; one 8110-045 cortical screw; one 8124-040 fully threaded cancellous locking screw; one 8124-044 fully threaded cancellous locking screw; three 8124-046 fully threaded cancellous locking screws; two 8124-048 fully threaded cancellous locking screws; and one 8124-050 fully threaded cancellous locking screw.The removal operative report confirmed that the alignment guide, all screws, and the original plate were removed.The patient¿s non-union was revised during the same procedure using a longer plate and screws.The manufacturer of the newly implanted hardware is unknown at this time.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), photographs, videos, event descriptions, and additional field data, arthrex was able to determine the most likely cause of the reported issue.According to the documented event details, the inadvertent retention of the targeter/drill guide from the initial procedure was most likely due to user error associated with suboptimal surgical technique.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM
• Common Device Name: FIXATN NAIL/BLADE/PLATE COMBO
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22586878
• Report Number: 1220246-2025-03046
• Device Sequence Number: 4502117
• Product Code: KTW
• UDI-Device Identifier: 00848665033670
• UDI-Public: (01)00848665033670(11)210730(10)0000AOS
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM
• Device Catalogue Number: 8124-048
• Device Lot Number: 0000AOS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown