MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM KNOTLESS SUTURETAK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.0MM KNOTLESS SUTURETAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
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 22-jan-2026, it was reported by a sales representative via (b)(4) that (qty.3) of an ar-8934bck knotless suturetaks were breaking down near the end on the insert.This was discovered during the case with no patient harm.

• Brand Name: 3.0MM KNOTLESS SUTURETAK
• 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: 24313159
• Report Number: 1220246-2026-00527
• Device Sequence Number: 5572362
• Product Code: MAI
• UDI-Device Identifier: 00888867380981
• UDI-Public: (01)00888867380981(11)250324(17)290228(10)15408396
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 3.0MM KNOTLESS SUTURETAK
• Device Catalogue Number: AR-8934BCK
• Device Lot Number: 15408396
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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