MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK, 3.5 X 13.5 MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX SWIVELOCK, 3.5 X 13.5 MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
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, a healthcare professional reported that an ar-3780sp knee fibertak button, an ar-8979p dx swivelock, and an ar-7500 suturetape were implanted in a patient during a surgical procedure.Approximately one year later, the patient began experiencing persistent pain and was referred to an allergist for an allergen patch test.No additional details were provided.
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 a patient-specific event.

• Brand Name: DX SWIVELOCK, 3.5 X 13.5 MM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 22125910
• Report Number: 1220246-2025-02343
• Device Sequence Number: 18018846
• Product Code: MBI
• UDI-Device Identifier: 00888867202900
• UDI-Public: 00888867202900
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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: DX SWIVELOCK, 3.5 X 13.5 MM
• Device Catalogue Number: AR-8979P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 10/08/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown