MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS; NON-DEGRADABLE FIXATN FASTENER

Model Number	KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
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.Complaint allegation is confirmed based on the photo provided by the reporter.Visual inspection revealed the suture is cut.The most likely cause of the reported failure can be attributed to user error due to excessive force used during suture pulling.
Event or Problem Description
On 3/29/2023, it was reported by a sales representative via email that the tensiontight locking button from an ar-2350 knotless tensiontight button implant system is cutting the number five fiberlink sutures once the button is flipped and tensioned.This was discovered during a proximal bicep repair procedure on (b)(6) 2023.The button was left inside the patient, and the sutures were removed.Additional information received on 12/11/2023: the button was not implanted, and the case was completed using an ar-2290 proximal tenodesis implant system.Other than the sutures, nothing broke inside the patient.

• Brand Name: KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
• 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: 19495288
• Report Number: 1220246-2024-05341
• Device Sequence Number: 15588048
• Product Code: MBI
• UDI-Device Identifier: 00888867301924
• UDI-Public: 00888867301924
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202444
• 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
• Report Date (Section B): 06/09/2024

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 Model Number: KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
• Device Catalogue Number: AR-2350
• Device Lot Number: 15048049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 06/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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