MAUDE Adverse Event Report: ARTHREX, INC. 2.6 DL KNOTLESS FIBERTAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	2.6 DL KNOTLESS FIBERTAK
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/21/2025
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 4/2/2025, a sales representative reported via phone that an ar-3642sp knotless 2.6 fibertak had an issue during a rotator cuff repair procedure on (b)(6) 2025.When the surgeon shuttled the two sutures through the anchor, the shuttle suture could not be looped through and ripped apart inside the patient.The sutures were cut and removed, and the anchor remained in one piece inside the patient.Nothing else broke inside the patient, and there was no harm.Another ar-3642sp knotless 2.6 fibertak with the same lot number was used to complete the procedure successfully.There was a 1-minute case delay, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.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 the 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.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: 2.6 DL KNOTLESS FIBERTAK
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 21865740
• Report Number: 1220246-2025-01567
• Device Sequence Number: 4719690
• Product Code: MBI
• UDI-Device Identifier: 00888867426429
• UDI-Public: (01)00888867426429(11)240705(17)290630(10)15282999
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K230433
• 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): 09/23/2025

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: 2.6 DL KNOTLESS FIBERTAK
• Device Catalogue Number: AR-3642SP
• Device Lot Number: 15282999
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2024
• 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