MAUDE Adverse Event Report: ARTHREX, INC. 3.5X38MM BEVELED FT SCREW; BONE FIXATION SCREW/PLATE

Model Number	3.5X38MM BEVELED FT SCREW
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a facility representative reported via email that an ar-8735bv-38 beveled ft screw was found to be prominently positioned in the mcp joint space.Surgical removal is planned for the end of (b)(6).This issue was identified post-implementation, with no additional details provided.Additional information was received on 08/26/2025: the patient underwent open reduction and internal fixation with an intramedullary screw for a right fifth metacarpal neck fracture with significant displacement on (b)(6) 2025.The arthrex product implanted during the procedure was the ar-8735bv-38 beveled ft screw (3.5 mm x 38 mm).During the procedure, the surgeon noted that the screw had been stripped and subsequently burred down the prominent portion.Final intraoperative x-rays confirmed that the screw was buried beneath the articular cartilage.The surgeon then assessed the small finger mcp joint through its range of motion.The fracture was stabilized, and there was no evidence of impingement from the implant.Screw prominence was first identified via x-ray imaging at the patient's routine four-week follow-up visit on (b)(6) 2025 (see attachment).During this appointment, the patient reported increased pain in the right small finger mcp joint.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 3.5X38MM BEVELED FT SCREW
• 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: 22962444
• Report Number: 1220246-2025-03727
• Device Sequence Number: 15554665
• Product Code: HWC
• UDI-Device Identifier: 00888867360822
• UDI-Public: 00888867360822
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K210994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: 3.5X38MM BEVELED FT SCREW
• Device Catalogue Number: AR-8735BV-38
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown