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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 03/24/2025, it was reported by a sales representative via email that an ar-8973r-30-180 arthrex fibulock nail broke at the tip of where the talons deploy during the beginning insertion of the nail.The talons were compromised and could not be deployed properly.There was an increase in case time, and anesthesia was increased by 15-20 minutes.The broken implant portion was left inside the patient.The broken piece was advanced up the canal to make sure that the final implant could be used.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 04/14/2025: no revision surgery is required because the broken fragment advanced up the canal of the fibula.They tried to remove the broken piece for a few minutes but elected to advance so as not to cause the patient harm.The patient did not experience a reduction in quality of life due to the deviation.The case was completed successfully using a fibulock nail.There were no adverse effects reported during or after the surgery.This occurred during an ankle fracture procedure on (b)(6) 2025.
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 the most likely cause of the reported failure is user error.This includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.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: 3.0X180MM 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: jared engle ; 8009337001
• MDR Report Key: 21864679
• Report Number: 1220246-2025-01550
• Device Sequence Number: 12734696
• Product Code: HSB
• UDI-Device Identifier: 00888867295230
• UDI-Public: (01)00888867295230(11)241219(17)291130(10)15364333
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/01/2025

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: 15364333
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: Not provided; 09/29/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 04/29/2025; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown