MAUDE Adverse Event Report: ARTHREX, INC. DUALCOMP HINDFOOT NAIL, 11.5 X 180 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	DUALCOMP HINDFOOT NAIL, 11.5 X 180 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
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-jan-2026, a sales representative reported via email that an ar-9090-05s dualcomp hindfoot nail (11.5 x 180 mm) experienced a cable break within the nail during tensioning at step 3 of the procedure while inside the patient.All fragments were successfully retrieved, and the case was completed by placing the remaining screws.The surgeon inserted the final screw after the cable failure and finished the procedure without delay or additional anesthesia.The patient¿s bone quality was assessed as neither excessively hard nor soft.This occurred during a ttc (tibiotalocalcaneal) fusion procedure on (b)(6) 2026, with no reported patient harm.

• Brand Name: DUALCOMP HINDFOOT NAIL, 11.5 X 180 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: 24211272
• Report Number: 1220246-2026-00339
• Device Sequence Number: 9635784
• Product Code: HSB
• UDI-Device Identifier: 00888867305533
• UDI-Public: (01)00888867305533(11)241211(17)291130(10)15360265
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/15/2026

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, 11.5 X 180 MM
• Device Catalogue Number: AR-9090-05S
• Device Lot Number: 15360265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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