MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100; SMOOTH FIXATION PIN

Model Number	IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10-feb-2026, it was reported by a health care provider via (b)(4) that a patient with an ar-4152ds trim-it drill pin is suspected to have a metal reaction to the product implanted on (b)(6) 2024.No further information was provided.Additional information provided on 16-feb-2026: it was further reported the patient underwent a hammertoe and neuroma correction.Since (b)(6) 2024, the toe has remained swollen (confirmed on a recent mri).The patient reports ongoing discomfort with unusual sensations, including a ¿zinging¿ feeling.The treating podiatrist suspects a possible hypersensitivity/allergic reaction to the dissolvable pin used in the procedure, which has not yet dissolved.Medical management has included steroid injections at the site without improvement.No arthrex device has been removed to date.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Common Device Name: SMOOTH FIXATION PIN
• 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: 24482205
• Report Number: 1220246-2026-01095
• Device Sequence Number: 16010036
• Product Code: HTY
• UDI-Device Identifier: 00888867032811
• UDI-Public: (01)00888867032811(11)220707(17)240630(10)14979006
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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 Expiration Date: 06/30/2024
• Device Model Number: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Device Catalogue Number: AR-4152DS
• Device Lot Number: 14979006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown