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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
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 06/25/2025, a facility representative reported via (b)(4) that an ar-9091-01 hindfoot nail targeting guide broke during a case.This did not affect patient outcome as they had a backup set at the time.No patient was affected.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.No problem found.The complaint allegation was not confirmed.One unpackaged ar-9091-01 batch 5572034a was received for evaluation.Visual inspection did not find broken parts on the device.The evaluation did not identify damage to the device.Functional testing was conducted by assembling a well-known connector and testing the locking mechanism, and no issues were found.The device is working as intended.

• 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: 22542445
• Report Number: 1220246-2025-02965
• Device Sequence Number: 8468256
• Product Code: HSB
• UDI-Device Identifier: 00888867335295
• UDI-Public: (01)00888867335295(11)201005(10)5572034A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K221031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 5572034A
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/11/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown