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

Model Number	KNEE FIBERTAK BUTTON
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
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, a sales representative reported via email that an ar-3780sp knee fibertak button experienced an issue during a triceps repair procedure on (b)(6) 2025.After implantation and removal from the introducer, it was noted that one of the shuttling sutures was lacerated, compromising the ability to shuttle the suture successfully through the implant.Despite the issue, the case was completed, and no patient harm was reported.No further details provided.Additional information was received on 07/28/2025: the issue with the ar-3780sp knee fibertak button was not noticed until after implantation.A backup anchor, the ar-3780sp knee fibertak button, was used to complete the procedure, resulting in a brief 5-minute delay without extra anesthesia.Bone socket preparation was performed with the ar-3710 kit using a 2.6 mm drill.Bone quality was normal, and no post-op complications were reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error of the device due to incorrect surgical technique during the mechanism conversion process, and/or excessive force applied during suture passage, which could compromise suture integrity.

• 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: 22730543
• Report Number: 1220246-2025-03292
• Device Sequence Number: 18228841
• Product Code: MBI
• UDI-Device Identifier: 00888867431669
• UDI-Public: (01)00888867431669(11)230927(17)280831(10)15146847
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 11/20/2025

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: 15146847
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown