MAUDE Adverse Event Report: ARTHREX, INC. THRDED G-WIRE,W/TRCR TIP,.062"; ORTHOPEDIC MANUAL SURG INSTR

Model Number	THRDED G-WIRE,W/TRCR TIP,.062"
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/18/2025, it was reported by a competent authority via (b)(4) that an ar-8941kt threaded guidewire tip had broken off into the bone.The surgeon was unable to retrieve broken fragment.This was discovered during a calcaneus procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information received on 3/24/2025: there was no delayed in the case, and additional anesthesia was not needed.The patient suffered no negative effects on or after the surgery.
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 misaligned insertion, prying/leveraging the device during insertion.

• Brand Name: THRDED G-WIRE,W/TRCR TIP,.062"
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21548837
• Report Number: 1220246-2025-00844
• Device Sequence Number: 17243752
• Product Code: LXH
• UDI-Device Identifier: 00888867051843
• UDI-Public: (01)00888867051843(11)241017(10)4254152579
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,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: THRDED G-WIRE,W/TRCR TIP,.062"
• Device Catalogue Number: AR-8941KT
• Device Lot Number: 4254152579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/24/2025; 08/27/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/21/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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