MAUDE Adverse Event Report: ARTHREX, INC. DUALCOMP HINDFOOT NAIL, 11.5 X 300 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	DUALCOMP HINDFOOT NAIL, 11.5 X 300 MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2024
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 (b)(6)2024, it was reported by a sales representative via email that a ttc nail and a drill bit from a compression ft system had issues during a procedure.No further information was provided.Additional information was received on 12/17/2024: the ar-9090-08s dualcomp hindfoot nail was implanted, and the drill would not advance into the nail when drilling for the proximal calcaneus.The surgeon attempted to freehand the drill without the jig but was unsuccessful.While using the ar-8750-09 cannulated drill bit, it snapped at the connection to the power adapter.The piece that broke off remained flush with the ao connection.The rest of the drill was removed from the guidewire in one piece.The drill did not break in the patient.The case was completed using additional fixation with an ar-8770-70h compression ft screw and an ar-8770-55h compression ft screw.The case was delayed about fifteen minutes; however, the sales representative was unaware if additional anesthesia was administered.This was discovered during a hindfoot arthrodesis, ttc fusion procedure on (b)(6)2024.
Additional Manufacturer Narrative
Additional information: the failed 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 concluded the most likely cause.The most likely cause of the reported failure is user error.The issues with the instrument ar-8750-09 caused problems during the procedure.The complaint was confirmed based on the customer's attached picture, which shows the device ar-8750-09 broken off at the connection to the power adapter.The failed 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 concluded the most likely cause.The most likely cause of the reported failure is user error.The issues with the instrument ar-8750-09 caused problems during the procedure.The complaint was confirmed based on the customer's attached picture, which shows the device ar-8750-09 broken off at the connection to the power adapter.

• Brand Name: DUALCOMP HINDFOOT NAIL, 11.5 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: 21027478
• Report Number: 1220246-2024-09083
• Device Sequence Number: 9004087
• Product Code: HSB
• UDI-Device Identifier: 00888867305564
• UDI-Public: 00888867305564
• 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
• Report Date (Section B): 07/21/2025

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 300 MM
• Device Catalogue Number: AR-9090-08S
• Device Lot Number: 15145915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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