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

Model Number	FIBERTAK BUTTON
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
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 (b)(6) 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 of the device due to excessive force being used when tensioning the sutures.
Event or Problem Description
On (b)(6)2021 it was reported by a sales representative via the phone that an ar-3680 (line #1) fibertak button pulled out of the bone when the surgeon converted the repair stitch after insertion, all the ar-3680 was removed.The surgeon opened an ar-3681 (line #2) using the same insertion site and the same issue occurred, all the ar-3681 was removed from the patient.This was discovered during use in a bicep tenodesis procedure on (b)(6)2021.The case was completed by opening a new ar-3680.

• 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: emily shafer ; 8009337001
• MDR Report Key: 19194154
• Report Number: 1220246-2024-02478
• Device Sequence Number: 15544005
• Product Code: MBI
• UDI-Device Identifier: 00888867305458
• UDI-Public: 00888867305458
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K231113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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: 12/02/2021
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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