MAUDE Adverse Event Report: ARTHREX, INC. LOCKING SCREW, TITANIUM 3.5MM X 18MM; BONE FIXATION SCREW/PLATE

Model Number	LOCKING SCREW, TITANIUM 3.5MM X 18MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2025
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 (b)(6) 2025, it was reported by a sales representative via phone that an plantar lapidus short plate was not allowing screw to lock in.This occurred during a lapidus arthrodesis on (b)(6) 2025, when the ar-8935l-14 and an ar-8935l-18 screws were not locking into the plate.Everything was removed from the patient and they proceeded to use a new plate that worked.The ar-8935l-18 screw worked with the new plate; the ar-8935l-14 was not used.
Additional Manufacturer Narrative
Additional information: ge, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause can be attributed to misuse due to improper bone preparation, misaligned insertion, or prying/leveraging the screw during insertion.

• Brand Name: LOCKING SCREW, TITANIUM 3.5MM X 18MM
• 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: 21545752
• Report Number: 1220246-2025-00838
• Device Sequence Number: 6999929
• Product Code: HWC
• UDI-Device Identifier: 00888867050891
• UDI-Public: 00888867050891
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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 18MM
• Device Catalogue Number: AR-8935L-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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
• Patient Sex: Unknown