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	Foreign Body Reaction (1868)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient¿s relative reported via phone that her husband developed an infection after a pectoralis major tendon repair procedure of the left pectoralis on (b)(6) 2025.Three unknown pec buttons were implanted in the patient.2 weeks after surgery, the patient had an infection and was put on antibiotics.In early (b)(6), the patient started to have issues again, and he developed a mass on his biceps, a granuloma, that would not heal.An mri was taken, and it showed edema.On (b)(6) 2025, a second surgery was performed by the same surgeon to clear the infection; nothing was explanted or implanted.Antibiotics were administered during the procedure, and samples were taken, which came back negative for infection.The surgery was deemed successful.The mass on the patient¿s arm is still present; it is an open wound with subcutaneous fat protruding through it.Metal allergy testing had been performed.The patient tested positive for cobalt alloy.The patient will see a wound specialist to help with wound closure.The patient¿s relative requested the material composition of the unknown implants and a metal-implants-and-nickel-sensitivity document.Additional information was requested.On 6/25/2025, the patient's relative provided the following additional information via email: she had not been able to obtain the product part numbers for the unk buttons, but an ar-7237-17n fibertape was also used in the procedure on (b)(6) 2025.Additional information was requested.On 6/26/2025, the patient's relative provided the following additional information via email: an ar-2269 implant delivery system, pec repair, large eyelets, with lot number 15332621, was used in the procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 for the reported failure can be attributed to a patient-specific event due to an infection.

• 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: 22508951
• Report Number: 1220246-2025-02875
• Device Sequence Number: 18340142
• Product Code: MBI
• UDI-Device Identifier: 00888867026582
• UDI-Public: (01)00888867026582(11)241016(17)290831(10)15332621
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: 15332621
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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