MAUDE Adverse Event Report: ARTHREX, INC. 2.4MM KNOTLESS SUTURETAK; POLYETHYLENE SYNTHETIC SUTURE

Model Number	2.4MM KNOTLESS SUTURETAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by sales representative via phone that three ar-3636h self bunching 1.8 knotless hip fibertak and an ar-2424phs peek, 2.4 mm knotless hip suturetak white shuttle suture snapped while flossing and shuttling the sutures.Some of the sutures were tied together and an ar-6955 hip labral reconstruction implant system was used to complete the case.The remaining sutures were cut out and removed.The case overall lasted two additional hours.This was discovered during a hip labral repair procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
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: 2.4MM KNOTLESS SUTURETAK
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 20857768
• Report Number: 1220246-2024-08726
• Device Sequence Number: 8729538
• Product Code: GAT
• UDI-Device Identifier: 00888867443624
• UDI-Public: (01)00888867443624(11)231019(17)280930(10)15156010
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K232340
• 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): 07/08/2025

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: 2.4MM KNOTLESS SUTURETAK
• Device Catalogue Number: AR-2424PHS
• Device Lot Number: 15156010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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