MAUDE Adverse Event Report: ARTHREX, INC. KNEE FIBERTAK W/ FIBERTAPE; NON-DEGRADABLE FIXATN FASTENER

Model Number	KNEE FIBERTAK W/ FIBERTAPE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 28-jan-2026, a sales representative reported via phone that an ar-3750sp knee fibertak anchor for the internalbrace and an ar-3780sp knee fibertak button both pulled out of the bone and did not achieve fixation.Both devices were removed, and the procedure was successfully completed using a replacement ar-3750sp knee fibertak anchor and an ar-1593-p secondary fixation with peek swivelock anchor implant system.No surgical delay or additional anesthesia was required.This event occurred during a distal mcl procedure performed on (b)(6) 2026, with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: KNEE FIBERTAK W/ FIBERTAPE
• 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: 24344822
• Report Number: 1220246-2026-00616
• Device Sequence Number: 15930721
• Product Code: MBI
• UDI-Device Identifier: 00888867434769
• UDI-Public: (01)00888867434769(11)250115(17)291231(10)15373679
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 06/12/2026

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: KNEE FIBERTAK W/ FIBERTAPE
• Device Catalogue Number: AR-3750SP
• Device Lot Number: 15373679
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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