MAUDE Adverse Event Report: ARTHREX, INC. GUIDEWIRE, 1.6MM, 4MM BEVELED FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GUIDEWIRE, 1.6MM, 4MM BEVELED FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
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 10/14/2025, an arthrex subsidiary employee reported via (b)(4) that an ar-8741-15 1.6 mm, 4mm beveled guidewire broke during a case with no patient affected.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on photographic evidence of an ar-8741-15, batch 1197808, that displays the broken guide wire.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is error, specifically misaligned insertion, prying/leveraging, and/or applying excessive force on the device during use.Per directions for use (dfu) dfu-0023-eo revision 5, instruments, i.Cautions 1.Users of this device are encouraged to contact their arthrex representatives if, in their professional judgment, they require a more comprehensive surgical technique or more information.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.2.To avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.3.Do not use arthrex instruments for any purpose other than their intended use.Manipulating soft tissue or bone with an instrument not intended for that use may result in damage to the instrument.

• Brand Name: GUIDEWIRE, 1.6MM, 4MM BEVELED FT
• 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: 23366134
• Report Number: 1220246-2025-04766
• Device Sequence Number: 12981701
• Product Code: LXH
• UDI-Device Identifier: 00888867362376
• UDI-Public: (01)00888867362376(11)241022(10)1197808
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: GUIDEWIRE, 1.6MM, 4MM BEVELED FT
• Device Catalogue Number: AR-8741-15
• Device Lot Number: 1197808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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