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	Defective Device (2588)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/4/2024, it was reported by a sales representative via email that two ar-3642sp knotless 2.6 fibertak had the tails showing out of the bone as well as the knotless mechanism.Both ar-3642sp knotless 2.6 fibertak had to be cut out and a 5.5 swivelock was inserted in place to complete the case.Some of the anchors is still in the patient's bone.This was discovered during an rcr procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 10/9/2024: the case was completed using an ar-2323bct-2 biocomposite swivelock.The case was not delayed, and additional anesthesia was not needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.

• 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: 20441172
• Report Number: 1220246-2024-08123
• Device Sequence Number: 7995180
• Product Code: MBI
• UDI-Device Identifier: 00888867426429
• UDI-Public: (01)00888867426429(11)240123(17)281231(10)15196911
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 07/07/2025

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: 15196911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 06/11/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 10/25/2024; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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