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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 3/8/2024, it was reported by a sales representative via phone that a surgeon has been using the mis bunion system for two years and was having difficulty with two arthrex products, the ar-8741-15 guidewire and the ar-300-b102 burr.When using the ar-8741-15 guidewire it keeps getting stuck when shooting the k-wire when drilling causing the surgeon to re-find the hole and start over again.When using the ar-300-b102 burr it keeps getting stuck when cutting with the burr and would no longer cut.The cases were completed and no adverse effects were reported on any patients.This was discovered during cases.
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 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.The complaint allegation was not confirmed as the device was not received for evaluation, and no evidence of the failure was provided.

• 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: 18981022
• Report Number: 1220246-2024-01660
• Device Sequence Number: 12386567
• Product Code: LXH
• UDI-Device Identifier: 00888867362376
• UDI-Public: 00888867362376
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: GUIDEWIRE, 1.6MM, 4MM BEVELED FT
• Device Catalogue Number: AR-8741-15
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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