MAUDE Adverse Event Report: ARTHREX, INC. HINDFOOT NAIL TARGETING GUIDE; INTRAMED FIXATN ROD AND ACCESS

Model Number	HINDFOOT NAIL TARGETING GUIDE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
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, it was reported by a sales representative via (b)(4) that an ar-9091-01 hindfoot nail is not lining up correctly.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.- one unpackaged ar-9091-01 outrigger targeting guide batch number: 5572034 was received for investigation.- visual evaluation noted surface damage on the device, specifically around the diameter of the calcaneal and talar screw entries.- the most likely cause for the reported failure can attributed to misuse due to applying excessive forces to the device.- refer to investigation photos.- complaint allegation is confirmed.

• Brand Name: HINDFOOT NAIL TARGETING GUIDE
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 22782268
• Report Number: 1220246-2025-03427
• Device Sequence Number: 18178975
• Product Code: HSB
• UDI-Device Identifier: 00888867335295
• UDI-Public: 00888867335295
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: HINDFOOT NAIL TARGETING GUIDE
• Device Catalogue Number: AR-9091-01
• Device Lot Number: 5572034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown