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

Model Number	LARGE PEC BUTTON KIT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/11/2023, it was reported by a sales representative via sems that (2) pec buttons from an ar-2269 pec button implant system could not be twisted off or loosened to deploy.Another ar-2269 pec button implant system was used to complete the case without further issues.This was discovered during a procedure on 3/28/2023.Additional information received on 4/13/2032: this was discovered during a pec repair procedure.
Additional Manufacturer Narrative
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 user-applied mechanical forces as the device was torqued.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.

• Brand Name: LARGE PEC BUTTON KIT
• 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: 19506263
• Report Number: 1220246-2024-05507
• Device Sequence Number: 3405017
• Product Code: MBI
• UDI-Device Identifier: 00888867026582
• UDI-Public: 00888867026582
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K123341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: LARGE PEC BUTTON KIT
• Device Catalogue Number: AR-2269
• Device Lot Number: 15037786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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