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	09/05/2024
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 9/5/2024, it was reported by a sales representative via phone that two ar-2424phs hip suturetak anchor bodies broke during insertion.The bone socket with an ar-2424dhc-1 disposables kit for 2.4 knotless hip suturetak.The surgeon felt the drill did not properly drill the correct size for the suturetak, the hole was not large enough.When the suturetak anchors were inserted, they broke.Everything was removed from inside the patient.This was discovered during a hip arthroscopy procedure on (b)(6) 2024.The case was not delayed.The case was completed using a 2.9 pushlock.
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 method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• 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: 20248196
• Report Number: 1220246-2024-07710
• Device Sequence Number: 7397916
• Product Code: GAT
• UDI-Device Identifier: 00888867443624
• UDI-Public: 00888867443624
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/11/2025

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: 2.4MM KNOTLESS SUTURETAK
• Device Catalogue Number: AR-2424PHS
• Device Lot Number: 15221266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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