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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 16-jan-2026, a sales representative reported via email that two ar-3740sp double loaded knotless knee fibertak anchors pulled out during a let knee procedure performed on (b)(6) 2026.The surgical team relocated the fixation sites and successfully implanted an additional ar-3740sp anchor, which held as intended.No patient harm was reported.Additional information was requested on 20-jan-2026.Additional information was received on 22-jan-2026: the procedure was delayed approximately 5¿10 minutes while attempts were made to place additional anchors.No additional anesthesia was administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 24278355
• Report Number: 1220246-2026-00447
• Device Sequence Number: 13243597
• Product Code: MBI
• UDI-Device Identifier: 00888867428041
• UDI-Public: (01)00888867428041(11)251001(17)300930(10)15507401
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/28/2026

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: 15507401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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