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

Model Number	KNEE FIBERTAK BUTTON
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/09/2024, it was reported by a sales representative via (b)(4) that an ar-3780sp knee fibertak® button pulled out.This occurred during use when they placed the anchor, they went to set the anchor and it pulled out instantly.The inserter also bent.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/15/2024 additional information was received by sales representative via email who stated that the procedure being performed was a quad tendon repair.A disposable drill and guide were used to prepare the bone socket for insertion.The patient's bone quality was great.The procedure was completed by using a new knew fibertak button anchor.Device was disposed of after the case.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.This includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device bending and the implant pulling out.The complaint allegation was confirmed based on the customer's attached picture, where the shaft of the instrument was noted to be bent.However, no evidence of button 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: 20515529
• Report Number: 1220246-2024-08223
• Device Sequence Number: 8497603
• Product Code: MBI
• UDI-Device Identifier: 00888867431669
• UDI-Public: (01)00888867431669(11)230907(17)280831(10)15138712
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 08/21/2025

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: 15138712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 08/15/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/20/2024; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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