MAUDE Adverse Event Report: ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT; INTRAMED FIXATN ROD AND ACCESS

Model Number	3.0X130MM FIBULA NAIL, LEFT
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 12/3/2024, it was reported by a sales representative via email that an ar-8973l-30-130 arthrex fibulock nail proximal talons were not opening.The proximal talon driver was not seated fully, there was a gap of approximately 2 mm gap, which prevented the actuation of the talons.This was discovered during a procedure on (b)(6)2024.The case was completed using another ar-8973l-30-130 arthrex fibulock nail.Additional information received on 12/13/2024: the actuation driver from the ar-8973ds fibulock implant system would not fully seat and the talons on the nail could not open.This was discovered during a bimalleolar ankle fracture procedure.The case was delayed about ten minutes to open a new nail and avoid further delays.
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 user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: 3.0X130MM FIBULA NAIL, LEFT
• 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: 21035026
• Report Number: 1220246-2024-09097
• Device Sequence Number: 18436813
• Product Code: HSB
• UDI-Device Identifier: 00888867295209
• UDI-Public: (01)00888867295209(11)240402(17)290331(10)15228436
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: 3.0X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-30-130
• Device Lot Number: 15228436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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