MAUDE Adverse Event Report: ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE; INTRAMED FIXATN ROD AND ACCESS

Model Number	FIBULOCK IMPLANT SYSTEM, STERILE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 18-feb-2026, an arthrex subsidiary employee reported via email that an ar-8973ds fibulock implant system experienced an issue.During a fibula fracture repair procedure performed on (b)(6) 2026, the surgeon attempted to place the 1.6 mm guidewire from the product across the fracture site.When reaming was performed with a 6.2 mm reamer, the guidewire fractured.The broken portion of the wire was retrieved, and the surgeon elected to switch fixation to a plate (no detailed part or lot information provided).The procedure was completed without incident.No significant surgical delay occurred, no additional anesthesia was administered, and no patient harm was reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: FIBULOCK IMPLANT SYSTEM, STERILE
• 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: 24574342
• Report Number: 1220246-2026-01342
• Device Sequence Number: 16071044
• Product Code: HSB
• UDI-Device Identifier: 00888867303041
• UDI-Public: (01)00888867303041(11)250815(17)300731(10)15483209
• 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): 07/07/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: FIBULOCK IMPLANT SYSTEM, STERILE
• Device Catalogue Number: AR-8973DS
• Device Lot Number: 15483209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown