MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2025
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 15th december 2025, it was reported by a distributor via email that for an ar-8978p, dx swivelock® sl, with forked eyelet, 3.5x8.5mm, the swivelock fork tip was broken during insertion.This was detected during use in a cmc arthritis procedure on (b)(6) 2025.The procedure was completed successfully as an additional swivelock was used.Ar-8978ds-01 and ar-1678-03 were used for hole preparation.Bone density test was not performed.No fragment was left inside the patient.The fork tip fragment was dropped on the floor but could not be found after surgery so the returned implant will not have the tip on the swivelock.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a user error, including improper bone preparation and/or improper surgical technique associated with the device.The complaint allegation was not confirmed.The customer-provided image showed the device; however, no image of the broken eyelet was received.

• Brand Name: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• 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: 23955636
• Report Number: 1220246-2026-00026
• Device Sequence Number: 9437609
• Product Code: MBI
• UDI-Device Identifier: 00888867193925
• UDI-Public: (01)00888867193925(11)250813(17)300731(10)15481842
• 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): 04/15/2026

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: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Device Catalogue Number: AR-8978P
• Device Lot Number: 15481842
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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
• Patient Sex: Unknown