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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/24/2025, a sales representative reported via email that an ar-2324kbcc biocomposite knotless swivelock anchor experienced an issue during a supraspinatus double-row repair.After insertion of the second lateral row, a dog-ear was identified anteriorly.The repair stitch from this anchor was passed through the dog-ear and subsequently shuttled through the anchor.While tensioning the repair suture, the eyelet detached from the anchor body, with the repair suture still attached (see photo attached).Despite this, the sutures from the medial row were appropriately tensioned, and the anchor body remained seated within the bone.No additional parts were used.The case was delayed two minutes to remove the eyelet and sutures.This was discovered during an arthroscopic rotator cuff repair procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 10/30/2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically improper bone preparation, excessive force, and/or incorrect surgical technique.The complaint allegation was confirmed upon reviewing the customer¿s attached picture, where a blue suture was observed attached to a piece of a broken tip eyelet.

• 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: 23451678
• Report Number: 1220246-2025-04962
• Device Sequence Number: 8056636
• Product Code: MAI
• UDI-Device Identifier: 00888867351288
• UDI-Public: (01)00888867351288(11)250513(17)290430(10)15435387
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/05/2026

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: 4.75MM BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KBCC
• Device Lot Number: 15435387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown