MAUDE Adverse Event Report: ARTHREX, INC. PEEK, SWIVELOCK FT, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK, SWIVELOCK FT, 4.75X19.1MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via email that for an ar-2324pct, suture anchor, peek swivelock®, 4.75 mm with closed peek eyelet and blue fibertape® loop, the swivelock cold welded.This was detected during use in a rcr procedure on (b)(6) 2025.The procedure was completed successfully as a new anchor was used.
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.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 misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: PEEK, SWIVELOCK FT, 4.75X19.1MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 21583932
• Report Number: 1220246-2025-00887
• Device Sequence Number: 8895835
• Product Code: MAI
• UDI-Device Identifier: 00888867098114
• UDI-Public: (01)00888867098114(11)241217(17)291130(10)15363190
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K101823
• 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): 09/09/2025

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: PEEK, SWIVELOCK FT, 4.75X19.1MM
• Device Catalogue Number: AR-2324PCT-1
• Device Lot Number: 15363190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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