MAUDE Adverse Event Report: ARTHREX, INC. DUALCOMP HINDFOOT NAIL, 10.5 X 300 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	DUALCOMP HINDFOOT NAIL, 10.5 X 300 MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 02/29/2024, it was reported by a sales representative via e-mail that an ar-9090-04s dualcomp hindfoot nail could not be implanted.This occurred during a dual compression ttc nail case when tensioning the cable for the compression mechanism; the handle maxed out in the tensioner.When they went to drill the proximal calcaneal screw (third screw into the nail), the trajectory through the jig was blocked by the internal sliding mechanism of the nail.It was at this point that they realized the internal slider had not reached its maximum distance.They tried to troubleshoot on the fly, seeing if they could force the slider down through a screw hole or see if anything was blocking the mechanism, but were unable to move the slider.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via e-mail that an ar-9090-04s dualcomp hindfoot nail could not be implanted.This occurred during a dual compression ttc fusion nail case when tensioning the cable for the compression mechanism; the handle maxed out in the tensioner.When they went to drill the proximal calcaneal screw (third screw into the nail), the trajectory through the jig was blocked by the internal sliding mechanism of the nail.It was at this point that they realized the internal slider had not reached its maximum distance.They tried to troubleshoot on the fly, seeing if they could force the slider down through a screw hole or see if anything was blocking the mechanism, but were unable to move the slider.There was noticeable wear and tear in the tensioner from the set screw sliding against the metal on its track up and down the tensioner.The surgeon had to abandon placing a screw into the proximal calcaneal slot, leaving only one point of fixation distally in the nail.Additionally, the screw could not be implanted in the talar hole since that was also blocked.The case was completed successfully.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is not confirmed.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 user error of the device due to a wrong alignment with the attachment button on the cable tensioning device and/or the stainless-steel cable has not been preloaded through the distal slider in the nail properly.

• Brand Name: DUALCOMP HINDFOOT NAIL, 10.5 X 300 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: 18916338
• Report Number: 1220246-2024-01512
• Device Sequence Number: 7042953
• Product Code: HSB
• UDI-Device Identifier: 00888867305526
• UDI-Public: 00888867305526
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 06/05/2025

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 300 MM
• Device Catalogue Number: AR-9090-04S
• Device Lot Number: 15152820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 05/16/2025
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 08/21/2024; 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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