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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/28/2024, it was reported by a sales representative via email that (2) ar-2424phs peek, 2.4 mm knotless hip suturetak broke during implantation.Anchors were placed through a dala portal using a straight guide from ar-2424dhs knotless hip suturetak disposables kit and the drill from an ar-2424df-19 1.9 mm flexible fluted drill for 2.4 mm knotless hip suturetak.The drill was chucked up 3mm shy of the black laser line to give further buffer room to clear bone and not have the anchor bottom out prematurely from residual left behind bone.The drill was cycled seven times.The anchor was implanted per technique with firm hand pressure to start then light mallets to the inserter.However, the anchors broke.All parts of the implants were retrieved, and no harm was caused to the patient.The labral repair was completed by implanting an ar-3636h self bunching 1.8 knotless hip fibertak in a new hole spaced responsibly away from the previously drill hole.This was discovered during a hip arthroscopy labral repair procedure on (b)(6) 2024.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer-provided pictures noted the anchor of an ar-2424phs peek, 2.4 mm knotless hip suturetak was damaged.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to excessive force during insertion, misaligned insertion and/or prying/leveraging 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: 19173167
• Report Number: 1220246-2024-02310
• Device Sequence Number: 7873889
• Product Code: GAT
• UDI-Device Identifier: 00888867443624
• UDI-Public: 00888867443624
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/12/2025

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: 15197651
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2024
• 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