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

Model Number	4.75MM PEEK KNOTLESS SWIVELOCK
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2025
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 08/27/2025, a sales representative reported via phone that (4) ar-2324kpslc peek knotless swivelock® suture anchor failed.This occurred during a revision achilles procedure on (b)(6) 2025.When passing the repair stitch instead of cinching down as it should, it would loosen up.Three of these four devices failed inside the patient; the fourth was tested in the case and also failed.Two of these devices remained in the patient and were secured.Additionally, a device from another manufacturer was used to complete the case.There was a slight delay in the procedure that did not require additional anesthesia.
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 improper insertion angle.

• Brand Name: 4.75MM PEEK KNOTLESS SWIVELOCK
• 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: 23061741
• Report Number: 1220246-2025-03872
• Device Sequence Number: 9849986
• Product Code: MAI
• UDI-Device Identifier: 00888867351332
• UDI-Public: (01)00888867351332(11)250325(17)300228(10)15409974
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 4.75MM PEEK KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KPSLC
• Device Lot Number: 15409974
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown