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

Model Number	KNEE FIBERTAK BUTTON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/01/2024, it was reported by a sales representative via phone that an ar-3780sp knee fibertak® buttons stitches broke.This occurred during a quad tendon repair on (b)(6) 2024 when they were shuttling the tapes the stitches broke.All fragments were retrieved from the patient.The case was completed using an ar-2324pslc swivelock.There was no harm to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported via email by a sales representative that an ar-3710 knee fibertak drill kit was used to prepare the bone prior to insertion of the anchor and that the bone quality was good.
Additional Manufacturer Narrative
Additional information: b5, 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 user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: KNEE FIBERTAK BUTTON
• 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: 20065609
• Report Number: 1220246-2024-07270
• Device Sequence Number: 7728779
• Product Code: MBI
• UDI-Device Identifier: 00888867431669
• UDI-Public: 00888867431669
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• 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): 06/23/2025

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: KNEE FIBERTAK BUTTON
• Device Catalogue Number: AR-3780SP
• Device Lot Number: 15089085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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