MAUDE Adverse Event Report: ARTHREX, INC. DUALCOMP HINDFOOT NAIL, 10.5 X 180 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	DUALCOMP HINDFOOT NAIL, 10.5 X 180 MM
Medical Device Problem Codes	Positioning Failure (1158); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/08/2025, it was reported by a sales representative via email that an ar-9090-01s dualcomp hindfoot nail set screws lost grip on the cable and the nitenol core retracted when compressing the dual compression hindfoot nail and rendered the nail unusable.The case was completed by successfully removing the nail and implanting another ar-9090-01s dualcomp hindfoot nail.This was discovered during a ttc fusion with an intramedullary nail procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
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 for the reported failure can be attributed to use error due likely due to improperly loading the cable tensioning wire.The dualcompression hindfoot nail surgical technique, lt1-000194-en-us_d, outlines the following in step 5: 5c.Secure one side of the cable with the torque-limiting hex driver by tightening the set screw in the cable-tensioning device until it clicks three times.Insert the second tail of the cable into the other side of the nail attachment arm.Prior to tightening the second set screw, remove the slack in the cable by sliding a finger over the cable from the secure end to open the end of the cable, then pinch it on either side of the dualcompression nail to maintain tautness.Note: do not turn the tensioning mechanism to remove slack from the cable.

• Brand Name: DUALCOMP HINDFOOT NAIL, 10.5 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: 21970037
• Report Number: 1220246-2025-01921
• Device Sequence Number: 12806283
• Product Code: HSB
• UDI-Device Identifier: 00888867305618
• UDI-Public: (01)00888867305618(11)240213(17)290131(10)15206195
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/10/2025

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 180 MM
• Device Catalogue Number: AR-9090-01S
• Device Lot Number: 15206195
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown