MAUDE Adverse Event Report: ARTHREX, INC. 3.0X180MM FIBULA NAIL, RIGHT; INTRAMED FIXATN ROD AND ACCESS

Model Number	3.0X180MM FIBULA NAIL, RIGHT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-8973r-30-180 fibulock® nail bent over sideways.This occurred during an open tibial fracture on (b)(6) 2023, after reaming the nail was inserted and after inserting the plate and the tip of the nail was bent over sideways the device was pulled out and the case was completed using a ar-8973r-30-130.There was no patient effect reported.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
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 can be attributed to misaligned insertion; or user error due to applying excessive force.

• Brand Name: 3.0X180MM FIBULA NAIL, RIGHT
• 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: emily shafer ; 8009337001
• MDR Report Key: 17497518
• Report Number: 1220246-2023-07467
• Device Sequence Number: 6392152
• Product Code: HSB
• UDI-Device Identifier: 00888867295230
• UDI-Public: 00888867295230
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/07/2025

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: 3.0X180MM FIBULA NAIL, RIGHT
• Device Catalogue Number: AR-8973R-30-180
• Device Lot Number: 14563587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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