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	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
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, it was reported by a distributor via email that for an ar-8979p, dx swivelock¿, 3.5 mm x 13.5 mm, the swivelock could not screw all the thread into the fibula.The surgeon tried to pull back and insert again but found the eyelet was stuck inside the fibula could not be removed.This was detected during use in an atfl repair procedure on (b)(6) 2025.The procedure was completed successfully as an additional swivelock was used.Ar-1678-03, ar-1678-05 were used as drill and tap for the fibular hole.No further action or surgery is needed because of the issue.Bone density test is not a standard protocol for atfl case in taiwan.
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 of the reported failure can be attributed to user error of the device due to improper bone prep and/or shallow driver engagement depth.

• 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: 23004957
• Report Number: 1220246-2025-03777
• Device Sequence Number: 10484721
• Product Code: MBI
• UDI-Device Identifier: 00888867202900
• UDI-Public: (01)00888867202900(11)241008(17)290930(10)15328907
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: DX SWIVELOCK, 3.5 X 13.5 MM
• Device Catalogue Number: AR-8979P
• Device Lot Number: 15328907
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown