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

Model Number	LARGE PEC BUTTON KIT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/29/2025, a sales representative reported via phone that a patient developed an infection after undergoing a pectoralis major procedure on (b)(6) 2025 where an ar-2269 implant delivery system was utilized.Additional information was provided on 07/29/2025 where the sales representative stated this occurred 8 days post op on (b)(6) 2025 infection discovered.The infection being treated, and the patient is recovering.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to a patient-specific event.

• 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: 22882869
• Report Number: 1220246-2025-03609
• Device Sequence Number: 9640645
• Product Code: MBI
• UDI-Device Identifier: 00888867026582
• UDI-Public: (01)00888867026582(11)250430(17)291231(10)15428899
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123341
• 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,Followup
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LARGE PEC BUTTON KIT
• Device Catalogue Number: AR-2269
• Device Lot Number: 15428899
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown