MAUDE Adverse Event Report: ARTHREX, INC. 2.4MM KNOTLESS SUTURETAK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	2.4MM KNOTLESS SUTURETAK
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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 (b)(6)2024, it was reported by a sales representative via phone that an ar-2424phs suture anchor had an issue during a hip labral repair procedure on (b)(6)2024.When the surgeon implanted the anchor, one of the sutures coming out of it had been pierced through by another suture, and the knotless mechanism did not work.The surgeon removed all sutures and the anchor in one piece from the patient.Nothing broke inside the patient, and there was no patient harm.Another ar-2424phs suture anchor with the same lot number was used to complete the procedure successfully.There was a slight case delay of a couple of minutes, and no additional anesthesia was administered.The complaint device was discarded, and no pictures were taken.This occurred during use with no reported patient harm.
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: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21157254
• Report Number: 1220246-2025-09459
• Device Sequence Number: 15361392
• Product Code: GAT
• UDI-Device Identifier: 00888867443624
• UDI-Public: (01)00888867443624(11)240212(17)290131(10)15205524
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/10/2025

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: 15205524
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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