MAUDE Adverse Event Report: ARTHREX, INC. 2.5 X 30MM PIP DART, PEEK, 10 DEGREE; SMOOTH FIXATION PIN

Model Number	2.5 X 30MM PIP DART, PEEK, 10 DEGREE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
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 09/09/2024, it was reported by a sales representative via phone that (2) ar-4154ps-3010 pip darts broke.This occurred during a hammertoes procedure on (b)(6) 2024 each time the joint was prepped and attempted to insert the anchor it broke off, this occurred with both devices.All fragments were retrieved from the patient.The patient had a decent bone quality, that was prepped using the drill in the kit.The case proceeded using different screws.The case took longer, but the representative was unsure if additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: g3, 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 for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: 2.5 X 30MM PIP DART, PEEK, 10 DEGREE
• 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: 20246429
• Report Number: 1220246-2024-07704
• Device Sequence Number: 7365606
• Product Code: HTY
• UDI-Device Identifier: 00888867242401
• UDI-Public: 00888867242401
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 2.5 X 30MM PIP DART, PEEK, 10 DEGREE
• Device Catalogue Number: AR-4154PS-3010
• Device Lot Number: 15059022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2023
• 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