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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 it was reported by a sales representative via phone that an ar-8973l-30-130 fibula nail had an issue.During an ankle fracture procedure on (b)(6) 2023 when the surgeon inserted the nail, he met resistance in the fibula and pulled it out.When the device was pulled out, it was noticed that the tip of the nail had broken off inside the fibula.The broken tip was buried deep into the fibula and could not be removed from the patient.The surgeon deemed it safe to leave it inside the patient's fibula.A drill bit was used to mallet the tip deeper into the fibula, and then another ar-8973l-30-130, with lot 15033165 was used to complete the procedure successfully with no patient harm.
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
Additional information.Complaint is confirmed.Visual evaluation noted that the nose cone was broken.No broken part was returned for investigation.The probable cause of this condition is excessive force/ friction during use or insertion.Functional testing was not performed due to the damage to the device.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17152374
• Report Number: 1220246-2023-06913
• Device Sequence Number: 17563668
• Product Code: HSB
• UDI-Device Identifier: 00888867295209
• UDI-Public: 00888867295209
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 3.0X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-30-130
• Device Lot Number: 13355779
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown