MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C, 5.5X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK SWIVELOCK C, 5.5X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2025
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 12th october 2025, it was reported by an arthrex employee via email that for an ar-2323pslc-1, suture anchor, peek swivelock® c, 5.5 mm x 19.1 mm, closed eyelet, when sutures were being loaded into a 5.5mm swivelock anchor, the retention suture holding the peek eyelet broke meaning the eyelet could no longer stay attached to the anchor by way of retention suture.This was detected during use in an acl repair on (b)(6) 2025.The procedure was completed successfully as a new swivelock was opened.
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 user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: PEEK SWIVELOCK C, 5.5X19.1MM
• 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: 23334862
• Report Number: 1220246-2025-04679
• Device Sequence Number: 21293395
• Product Code: MAI
• UDI-Device Identifier: 00888867097964
• UDI-Public: (01)00888867097964(11)240812(17)290731(10)15300902
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K203495
• 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): 12/15/2025

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 C, 5.5X19.1MM
• Device Catalogue Number: AR-2323PSLC-1
• Device Lot Number: 15300902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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