MAUDE Adverse Event Report: ARTHREX, INC. DOUBLE LOADED KNOTLESS FIBERTAK, KNEE; NON-DEGRADABLE FIXATN FASTENER

Model Number	DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
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 30-jan-2026, a sales representative reported via phone that (2) ar-3770sp hybrid knee fibertak® anchors and (2) ar-3740sp double loaded knotless knee fibertak® anchors backed out.This occurred during an mpfl reconstruction on 30-jan-2026 when all (4) devices backed out of the patient.The patient had very good bone quality, which was prepped using an ar-3712-29 2.9mm drill for knee fibertaks.These failures resulted in a 15-minute delay which no additional anesthesia was administered.The procedure was completed using an ar-2324kbcc biocomposite knotless swivelock® anchor, and an ar-3740sp double loaded knotless knee fibertak® anchor.There was no harm to the patient.

• Brand Name: DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
• 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: 24376528
• Report Number: 1220246-2026-00638
• Device Sequence Number: 5649971
• Product Code: MBI
• UDI-Device Identifier: 00888867428041
• UDI-Public: (01)00888867428041(11)250423(17)300331(10)15424934
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• 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): 06/01/2026

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: DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
• Device Catalogue Number: AR-3740SP
• Device Lot Number: 15424934
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown