MAUDE Adverse Event Report: ARTHREX, INC. DX KNOTLESS FIBERTAK IMPLANT KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX KNOTLESS FIBERTAK IMPLANT KIT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
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 (b)(6) 2025, it was reported by a sales representative via phone that an ar-8991cp dx knotless fibertak implant kit, when opened, did not have purple markings on the suture to indicate where to shuttle the suture from.They guessed and implanted the implant, but the anchor failed and pulled out.Anchor and suture were removed from the patient.They used another ar-8991cp dx knotless fibertak implant kit from a different, unknown lot without any issues.No photos were taken of the complaint.The case was delayed five minutes due to the issue.This was discovered during a lateral ankle stabilization procedure on (b)(6) 2025, with no reported patient harm.
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 use error.

• Brand Name: DX KNOTLESS FIBERTAK IMPLANT KIT
• 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: 21882027
• Report Number: 1220246-2025-01633
• Device Sequence Number: 12954085
• Product Code: MBI
• UDI-Device Identifier: 00888867424715
• UDI-Public: (01)00888867424715(11)250226(17)291231(10)15395932
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• 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): 09/23/2025

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: DX KNOTLESS FIBERTAK IMPLANT KIT
• Device Catalogue Number: AR-8991CP
• Device Lot Number: 15395932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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