MAUDE Adverse Event Report: ARTHREX, INC. 3.8X180MM FIBULA NAIL, LEFT; INTRAMED FIXATN ROD AND ACCESS

Model Number	3.8X180MM FIBULA NAIL, LEFT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via email that an ar-8973l-38-180 arthrex fibulock nail talons never deployed.This was discovered during a fibulock nail procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 10/23/2024: this was discovered while the nail was already in the patient.Nothing broke off in the patient.The case was completed using an ar-8973l-30-180 arthrex fibulock nail, a smaller nail.The case was only delayed long enough to get the nail.Additional anesthesia was not needed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.This includes improper surgical technique.According to the fibulock® fibular nail system surgical technique.Actuate the talons: step 9.Confirm the outrigger is positioned lateral prior to actuation.Remove the impactor cap.Insert the actuation driver.Hold the outrigger while actuating to prevent rotation.Turn the actuation driver until it ¿clicks¿ to deploy the talons.The talons may not deploy fully in a tight canal.Do not rotate the nail after talon actuation.K-wires can be placed through the outrigger to control rotation provisionally.3 mm nail talons expand to 5 mm 3.8 mm nail talons expand to 6 mm.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was received.

• Brand Name: 3.8X180MM 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: 20522113
• Report Number: 1220246-2024-08231
• Device Sequence Number: 15446089
• Product Code: HSB
• UDI-Device Identifier: 00888867295261
• UDI-Public: (01)00888867295261(11)240821(17)290731(10)15305769
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 08/15/2025

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: 3.8X180MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-38-180
• Device Lot Number: 15305769
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided; 08/15/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/07/2024; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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