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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2025
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), it was reported by a sales representative via sems-(b)(4) that an ar-9091-01 hindfoot nail targeting guide was not aligning correctly for the proximal calcaneal screw.Fluoroscopic imaging confirmed that the screw slot was fully opened; however, the drill continued to contact metal instead of entering the slot.This was discovered during a pantalar arthrodesis using the ttc hindfoot nail procedure with no patient harm reported.To complete the case, the jig was repositioned to a medial-to-lateral orientation, and the team free-drilled to locate the slot within the nail, allowing measurement and implantation of the screw.

• 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: 24618274
• Report Number: 1220246-2026-01459
• Device Sequence Number: 9586201
• Product Code: HSB
• UDI-Device Identifier: 00888867335295
• UDI-Public: (01)00888867335295(11)201005(10)5572034A
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K221031
• 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): 06/12/2026

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: HINDFOOT NAIL TARGETING GUIDE
• Device Catalogue Number: AR-9091-01
• Device Lot Number: 5572034A
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown