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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-dec-2025, a sales representative reported via email that one of the proximal talons of an ar-8973l-30-130 arthrex fibulock nail, 3.0 x 130 mm left, broke off inside the patient during nail insertion.This was discovered during a fibulock procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on (b)(6) 2025: the procedure was completed using a replacement ar-8973l-30-130 arthrex fibulock nail (3.0 mm x 130 mm).The surgery experienced an approximate one-hour delay; administration of additional anesthesia could not be confirmed.During the procedure, one proximal talon fractured and remained unretrievable within the fibular canal.No adverse patient effects have been reported, and no additional surgery is planned due to the issue.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d4, g3, h3, h6.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 the complaint allegation was confirmed.One unpackaged ar-8973l-30-130, batch 15191059, with laser mark 15160325, was received for evaluation.Visual inspection revealed that one of the nail¿s winds was broken off.The metal section where the wind was seated was observed to be bent.A functional test was not performed due to the damage to the implant.The most likely cause of the reported failure is a user error, including improper bone preparation, excessive force, and/or misalignment of the insertion.Direction for use dfu-0271-eor1_fmt_en fibulock nail ankle fracture system.G.Precautions 4.Implants should not be forced, twisted, bent, or pried during insertion as this may damage, break, or bend the implant and render it unusable.Damaged implants should not be implanted.

• 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: jared engle ; 8009337001
• MDR Report Key: 23908469
• Report Number: 1220246-2025-05874
• Device Sequence Number: 18415311
• Product Code: HSB
• UDI-Device Identifier: 00888867295209
• UDI-Public: 00888867295209
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/13/2026

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: 3.0X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-30-130
• Device Lot Number: 15191059
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 02/10/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/05/2026; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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