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	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/10/2025, it was reported by a sales representative via phone that an ar-9090-02s dualcomp hindfoot nail nitinol cord became loose.This occurred during hindfoot fusion on (b)(6) 2025, when they got the implant in and the nitinol cord became loose or did not work.Everything was removed.The case continued using another nail.There was a delay of about 30 minutes and it is unknown if additional anesthesia was administered.There was no harm to the patient.
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.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including failure to follow the device surgical technique.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• 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: 21895599
• Report Number: 1220246-2025-01688
• Device Sequence Number: 8162163
• Product Code: HSB
• UDI-Device Identifier: 00888867305502
• UDI-Public: (01)00888867305502(11)240131(17)281231(10)15200915
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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, 10.5 X 210 MM
• Device Catalogue Number: AR-9090-02S
• Device Lot Number: 15200915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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