MAUDE Adverse Event Report: ARTHREX, INC. DUALCOMP HINDFOOT NAIL, 11.5 X 210 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	DUALCOMP HINDFOOT NAIL, 11.5 X 210 MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
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 3/3/2025, a sales representative reported via phone that an ar-9090-06s dualcomp hindfoot nail had an issue during a hindfoot nail procedure on (b)(6) 2025.During the tensioning portion of the case, the cable frayed, and the inner core of the nail could not be tensioned.The hindfoot nail was explanted from the patient in one piece together with the frayed cable.Everything was removed from the patient, nothing broke inside the patient, and there was no harm.The screws were also explanted and then reused together with a new ar-9090-06s dualcomp hindfoot nail with the same lot number, and the procedure was completed successfully.The complaint device was discarded, but pictures were taken.The case was delayed for more than 15 minutes, and it could not be confirmed if additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an unpackaged ar-9090-06s, with batch number 15239133, revealed damaged wires.Therefore, arthrex was able to deduce the cause of the complaint as user error due to excessive user-applied mechanical forces.

• Brand Name: DUALCOMP HINDFOOT NAIL, 11.5 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: 21632685
• Report Number: 1220246-2025-01000
• Device Sequence Number: 18460711
• Product Code: HSB
• UDI-Device Identifier: 00888867305540
• UDI-Public: (01)00888867305540(11)240424(17)290331(10)15239133
• 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): 09/12/2025

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: DUALCOMP HINDFOOT NAIL, 11.5 X 210 MM
• Device Catalogue Number: AR-9090-06S
• Device Lot Number: 15239133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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