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

Model Number	4.75MM BC KNOTLESS SWIVELOCK
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/24/2025, a sales representative reported via (b)(4) that an ar-2324kbcc biocomposite knotless swivelock® anchor had the entire knotless mechanism pop out of the anchor as a failure.This occurred during a case.The anchor body itself is still in the patient, but the knotless mechanism is not a part of the anchor at all, the suture was retrieved.This was an older patient with decent bone quality.
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 user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: 4.75MM BC 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: 22773002
• Report Number: 1220246-2025-03407
• Device Sequence Number: 9342084
• Product Code: MAI
• UDI-Device Identifier: 10888867351285
• UDI-Public: 10888867351285
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/11/2025

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 BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KBCC
• Device Lot Number: 15229901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown