MAUDE Adverse Event Report: ARTHREX, INC. .045" GUIDE WIRE TROCAR, THREADED; ARTHROSCOPIC ACCESSORIES

Model Number	.045" GUIDE WIRE TROCAR, THREADED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/20/2025
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, a competent authority reported via email that the tip of an ar-8737-42 threaded guide wire broke intraoperatively inside the patient's right wrist.The surgeon attempted retrieval but was unsuccessful, and the tip remains in the patient's wrist.The surgeon and surgical team have been made aware.This was discovered during a procedure on (b)(6) 2025.Additional information requested on 5/12/2025: the orthopedic procedure was successfully completed.The surgery experienced a 15-minute delay before proceeding as planned.However, no additional anesthesia was administered to the patient beyond the initial preparation.
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: .045" GUIDE WIRE TROCAR, THREADED
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 22124436
• Report Number: 1220246-2025-02338
• Device Sequence Number: 7484444
• Product Code: NBH
• UDI-Device Identifier: 00888867127203
• UDI-Public: 00888867127203
• 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,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: .045" GUIDE WIRE TROCAR, THREADED
• Device Catalogue Number: AR-8737-42
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown