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

Model Number	FIBERTAK BUTTON
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2022
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 is confirmed based on the customer provided photo, which displays the suture anchor assemblies that had pulled out.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 of the device due to excessive force during tensioning and/or improper bone prep.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via phone that ar-3680 fibertak pulled out of implantation site.A new tunnel was opened and an ar-3681 fibertak was opened, this one too, pulled out of implantation site.Case was completed by using a 7x10 tenodesis screw.This was discovered during a bicep tenodesis procedure on (b)(6) 2022.

• Brand Name: FIBERTAK BUTTON
• Common Device Name: NON-DEGRADABLE FIXATION 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: 19277385
• Report Number: 1220246-2024-03007
• Device Sequence Number: 20416993
• Product Code: MBI
• UDI-Device Identifier: 00888867305458
• UDI-Public: 00888867305458
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K231113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 12512254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown