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	05/15/2025
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 had alignment issues and an ar-9091-02 hindfoot nail cable tensioner would not tension.This was discovered during an pantalar arthrodesis for charcot foot with usage of ttc nail procedure with no patient harm.It was reported that during the procedure, the ar-9091-02 hindfoot nail cable tensioner did not fully open the proximal calcaneal screw slot.The device was removed while the nail remained in the patient and was reset to zero tension.The cables were then re-routed through the reset cable tensioner in an attempt to open the proximal calcaneal slot; however, the slot did not fully open as the device appeared unable to maintain full tension.The ar-9091-01 hindfoot nail targeting guide did not align with the screw slot.The case was completed using instruments from the 5.0/7.0 tray, placing a 1.6 wire and drilling with a 3.2¿mm cannulated drill to create the tunnel, after which the 5.0 screw from the hindfoot set was placed.

• 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: 24617945
• Report Number: 1220246-2026-01454
• Device Sequence Number: 21366842
• 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): 07/08/2026

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: 07/02/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 07/08/2026
• 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