MAUDE Adverse Event Report: ARTHREX, INC. LOCKING SCREW, TITANIUM 3.5MM X 14MM; BONE FIXATION SCREW/PLATE

Model Number	LOCKING SCREW, TITANIUM 3.5MM X 14MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 30-jan-2026, an arthrex employee reported via phone that (2) ar-8935l-14 low profile locking screws failed to lock into the plate.This occurred during an ankle fracture case on (b)(6) 2026.The case was completed using additional ar-8935l-14 low profile locking screws.There was no delay in the procedure, and no harm to the patient.

• Brand Name: LOCKING SCREW, TITANIUM 3.5MM X 14MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 24376718
• Report Number: 1220246-2026-00642
• Device Sequence Number: 5676083
• Product Code: HWC
• UDI-Device Identifier: 00888867050402
• UDI-Public: (01)00888867050402(11)250722(10)15470725
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: LOCKING SCREW, TITANIUM 3.5MM X 14MM
• Device Catalogue Number: AR-8935L-14
• Device Lot Number: 15438716
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown