MAUDE Adverse Event Report: ARTHREX, INC. 3.8X130MM FIBULA NAIL, LEFT; INTRAMED FIXATN ROD AND ACCESS

Model Number	3.8X130MM FIBULA NAIL, LEFT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/17/2025, a sales representative reported via phone that an ar-8973l-38-130 arthrex fibulock nail had an issue during a fibula fracture repair procedure on (b)(6) 2025.When the surgeon used the nail, the talons of the device were not deployed inside the patient.Nothing broke off the fibulock nail, and the device was removed in one piece from the patient; there was no harm.The complaint device was discarded, and no pictures were taken.An ar-8973l-38-180 arthrex fibulock nail with lot number 14895094 was used to complete the procedure successfully.The case was delayed for 3-4 minutes, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
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.The complaint 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 was able to conclude the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation, improper device surgical technique.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: 3.8X130MM 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: 21941854
• Report Number: 1220246-2025-01819
• Device Sequence Number: 8836006
• Product Code: HSB
• UDI-Device Identifier: 00888867295247
• UDI-Public: (01)00888867295247(11)210806(17)260731(10)13875117
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/03/2025

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 Expiration Date: 07/31/2026
• Device Model Number: 3.8X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-38-130
• Device Lot Number: 13875117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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