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	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was received on 19-aug-2026: the implant came out after insertion while the anchor was being set.No damage was observed on the implant, sutures, or inserter prior to use.The procedure was delayed by a couple of minutes while a replacement implant was opened.The case was completed using another ar-3740spr-3740sp double loaded knotless fibertak.No additional surgical intervention or anesthesia was required.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.

• 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50344857
• Report Number: 1220246-2026-04410
• Device Sequence Number: 20339683
• Product Code: MBI
• UDI-Device Identifier: 00888867428041
• UDI-Public: (01)00888867428041(11)260501(17)310430(10)15615377
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/08/2026

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: 15615377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown