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 Codes	Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/04/2025, it was reported by a sales representative via phone that an ar-8973l-30-130 arthrex® fibulock® nails talons would not deploy.This occurred during an ankle fracture procedure on (b)(6) 2024 when the surgeon went to advance the nail that the talons would not deploy.Another ar-8973l-30-130 arthrex® fibulock® nail was used to complete the case.There was no patient harm.The patient did not have a great bone quality.This resulted in a few minutes delay while removing the nail.Additional anasthesia is not believed to have been administered.
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 user error.

• 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: 21642406
• Report Number: 1220246-2025-01014
• Device Sequence Number: 15341878
• Product Code: HSB
• UDI-Device Identifier: 00888867295209
• UDI-Public: (01)00888867295209(11)230116(17)271231(10)15044982
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• 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): 09/12/2025

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: 15044982
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• 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