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

Model Number	KNEE FIBERTAK BUTTON
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
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 11/12/2025, it was reported by a sales representative via email that an ar-3780sp knee fibertak button would not allow the sutures to shuttle through the anchor.The anchor was used with an ar-3710 disposables kit and 1.3 suturetape exactly as intended; however, the sutures would not shuttle at all.The anchor was drilled out and replaced.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 11/17/2025: the event occurred during a distal biceps repair procedure on (b)(6) 2025.The case was completed using a replacement ar-3780sp knee fibertak button.The procedure was delayed to remove the initial anchor and insert a new one.The exact duration of the delay and whether additional anesthesia was administered to the patient remain uncertain.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a user error, including improper bone preparation and/or improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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: 23705625
• Report Number: 1220246-2025-05351
• Device Sequence Number: 16100989
• Product Code: MBI
• UDI-Device Identifier: 00888867431669
• UDI-Public: (01)00888867431669(11)241021(17)290930(10)15334431
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/11/2026

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 BUTTON
• Device Catalogue Number: AR-3780SP
• Device Lot Number: 15334431
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown