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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 (b)(6) 2025, an arthrex subsidiary employee reported via email that an ar-8973l-38-130 fibulock nail became overly tight during insertion and could not be fully seated.The insertion sequence involved using the ar-8973ds, guide pin placement, drilling with a 6.2 mm bit followed by a 3.2 mm bit and inserting the ar-8973l-38-130 fibulock nail.Due to the tight fit, the nail was removed for re-drilling with a 4.0 mm bit; however, the tip of the nail remained lodged in the medullary cavity.A long guidewire from a non-arthrex product was used to access the cavity via the fibular head and dislodge the retained fragment distally, allowing for removal.The case was completed using an ar-8973l-30-130 fibulock nail.This was discovered during a fibula fracture procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 06/25/2025: the ar-8973l-38-130 fibulock nail tip was lodged in the medullary cavity at a depth of 2/3 of the product, and there was resistance upon insertion.The tightness occurred progressively upon insertion.The patient's bone quality was assessed as normal.There was no case delay or added anesthesia administered to the patient.No adverse effects were reported on or following the surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 for the reported failure can be attributed to use error due to improper bone preparation.The fibulock fibular nail system surgical technique, lt1-00099-en_f, notes the following under proximal reaming: 3.2 mm reamer = 3.0 mm nail, 4.0 mm reamer = 3.8 mm nail.

• 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: 22440243
• Report Number: 1220246-2025-02773
• Device Sequence Number: 11910370
• Product Code: HSB
• UDI-Device Identifier: 00888867295247
• UDI-Public: (01)00888867295247(11)240314(17)290228(10)15220220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: 3.8X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-38-130
• Device Lot Number: 15220220
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown