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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/13/2025, an arthrex subsidiary employee reported via email that an ar-8973r-30-180 arthrex fibulock nail had an issue after being inserted.During the procedure, the device was inserted, but when attempting to insert the product a little deeper before opening the talon, the talon could not be fully closed.As a result, further insertion was stopped, and the device was removed.A replacement ar-8973r-30-180 arthrex fibulock nail was used instead.This was discovered during a procedure on (b)(6) 2025, 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: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-8973r-30-180 fibulock nail was received for investigation.Visual evaluation of the returned device noted the talons of the device were deployed.Functional testing was performed with a known good actuation driver and it was found that the talons could not be deactivated.The most likely cause for the reported failure can be attributed to use error due to improper bone preparation as it is likely the canal had not been reamed to the depth the surgeon was trying to push it into, which could have compressed the nose cone of the device, deforming the talons or talon windows and preventing the wedge that expands the talons to translate downward and open/close the talons.Refer to investigation photos.

• 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: 22151310
• Report Number: 1220246-2025-02397
• Device Sequence Number: 18095857
• Product Code: HSB
• UDI-Device Identifier: 00888867295230
• UDI-Public: (01)00888867295230(11)241017(17)290930(10)15333266
• 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): 10/09/2025

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: 15333266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 05/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown