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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
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) 2026, it was reported by an arthrex subsidiary employee via (b)(4) that a qty.2 of ar-8978p dx swivelocks broke.It was reported that at the moment of anchor insertion, one of the tips broke.Then during insertion, one of the fork tips broke.This was discovered during use with no patient harm.The case was completed with a third anchor.

• 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: 24430157
• Report Number: 1220246-2026-00891
• Device Sequence Number: 10253946
• Product Code: MBI
• UDI-Device Identifier: 00888867193925
• UDI-Public: (01)00888867193925(11)250519(17)300430(10)15438348
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150648
• 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): 06/23/2026

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: 15438348
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown