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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient contacted customer service requesting the material composition of a right fibula nail 3.0 by 130 mm.No allegation of product deficiency or adverse event was reported within this inquiry.On (b)(6) 2025, the patient reported via phone to have been experiencing difficulty walking and constant pain.The patient stated that the screws appear to be protruding and can be seen on the skin of the knee.The patient underwent tibial surgery due to an accident about a year and a half ago in which screws and the tibial nail was implanted.The patient reports to be highly allergic to titanium; however, post operation, the patient had a three weeklong metal testing, which came back negative for allergies.The patient was not tested for allergies prior to the surgery.No further information was provided.Additional information was received on 2/14/2025: it was reported by the patient via email that an ar-8973ds fibulock implant system, a 1109-300 tibial nail, an 8001-040 captured cortical screw, two 8001-034 captured cortical screw, two 8001-044 captured cortical screw, an ar-8973l-30-130 arthrex fibulock nail, an ar-8830-16 fully threaded cancellous screw, and an ar-8925ss syndesmosis tightrope xp were implanted during the initial surgery on (b)(6) 2024.The implants remain in the patient and a revision surgery has not been scheduled.No further information was provided.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on photographic evidence, via an x-ray, provided from the field.Therefore, arthrex was able to deduce a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• 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: 21447436
• Report Number: 1220246-2025-00625
• Device Sequence Number: 20773665
• Product Code: HSB
• UDI-Device Identifier: 00888867303041
• UDI-Public: (01)00888867303041(11)230210(17)280131(10)15055296
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 15055296
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• 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