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	01/14/2026
Type of Reportable Event	Malfunction
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 a pantalar arthrodesis procedure with an hour-long delay experienced and no patient harm reported.It was reported that after implantation of the nail and placement of the first and second construct screws, the ar-9091-02 hindfoot nail cable tensioner failed to maintain cable tension.The tibial screw was removed, and the device was taken off the implanted nail.A second compression device was applied, the tibial screw was reinserted, and compression was achieved using a backup tensioner.Fluoroscopy confirmed tension and full opening of the screw slots.Following this, the ar-9091-01 hindfoot nail targeting guide did not align with the third construct screw (proximal posterior-to-anterior calcaneal screw).Excessive movement in the targeting slot for screw 3 was noted, resulting in missed alignment both proximally and medial-laterally.The case was completed without any harm to patient and implant successfully was used.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 24617397
• Report Number: 1220246-2026-01450
• Device Sequence Number: 18600434
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown