MAUDE Adverse Event Report: ARTHREX, INC. DUALCOMP HINDFOOT NAIL, 10.5 X 210 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	DUALCOMP HINDFOOT NAIL, 10.5 X 210 MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/26/2025, it was reported by a sales representative via (b)(4) that an ar-9090-02s dualcomp hindfoot nail did not align properly with the guided arm and jig.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to user error of the device due to misaligned insertion.

• Brand Name: DUALCOMP HINDFOOT NAIL, 10.5 X 210 MM
• 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: 23064502
• Report Number: 1220246-2025-03885
• Device Sequence Number: 21343253
• Product Code: HSB
• UDI-Device Identifier: 00888867305502
• UDI-Public: (01)00888867305502(11)250416(17)300331(10)15421816
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: DUALCOMP HINDFOOT NAIL, 10.5 X 210 MM
• Device Catalogue Number: AR-9090-02S
• Device Lot Number: 15421816
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown