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

Model Number	FIBERTAK BUTTON
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.
Event or Problem Description
On 9/29/2022, it was reported by an arthrex employee via email that an while using an ar-3680 fibertak button kit, the implant pulled out.Surgeon opened an ar-3681 fibertak button along with an ar-7535 fiberlink suture tape which also pulled out.Finally case was completed with a product from another manufacturer.This was discovered during an unspecified procedure on (b)(6) 2022.Additional information received on 10/4/2022: this was discovered during an rcr procedure and nothing broke inside the patient.

• Brand Name: 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: 19281052
• Report Number: 1220246-2024-03055
• Device Sequence Number: 12342419
• Product Code: MBI
• UDI-Device Identifier: 00888867305458
• UDI-Public: 00888867305458
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K231113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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 Expiration Date: 12/31/2025
• Device Model Number: FIBERTAK BUTTON
• Device Catalogue Number: AR-3681
• Device Lot Number: 12547012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2021
• 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