MAUDE Adverse Event Report: ARTHREX, INC. FT STERNAL CLOSURE W/ TAPER CUTTING NDL; FIXATION CERCLAGE

Model Number	FT STERNAL CLOSURE W/ TAPER CUTTING NDL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	03/14/2025
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 4/9/2025, an fda medwatch notification was received via email.A facility representative reported that a patient underwent an aortic valve replacement, tissue and coronary artery bypass graft, and repair tricuspid valve procedure in (b)(6) 2025.The patient's sternal closure was achieved with an ar-7288 fibertape sternal closure.The patient then presented with a sternal wound infection, requiring additional surgery.Surgical cultures revealed corynebacterium amycolatum.No additional information was provided.
Event or Problem Description
Additional information received on 4/16/2025: the facility representative confirmed that, in addition to the ar-7288 fibertape sternal closure, an ar-7289t tigertape sternal closure, and an ar-7288t tigertape sternal closure were implanted during the initial surgery on (b)(6) 2025.The patient began experiencing symptoms on (b)(6) 2025, including chest pain, chest wall abscess, and mediastinitis.The infection, identified as corynebacterium amycolatum, required multiple treatments, including debridement and irrigation of the chest, a pectoralis muscle flap for closure, and wound vacuum-assisted closure.These interventions were performed on (b)(6) 2025.During an additional surgical procedure, the implants were explanted; however, the specific implants removed and the exact date of the surgery remain unclear.The patient was discharged on (b)(6) 2025 with jp drains in place and continued iv antibiotic therapy via a picc line.Additional information has been requested on 5/8/2025.
Additional Manufacturer Narrative
Additional information: b5, g3.
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 can be misuse due to a patient-specific event.

• Brand Name: FT STERNAL CLOSURE W/ TAPER CUTTING NDL
• Common Device Name: FIXATION CERCLAGE
• 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: 21909096
• Report Number: 1220246-2025-01738
• Device Sequence Number: 4084654
• Product Code: GAT
• UDI-Device Identifier: 00888867369856
• UDI-Public: 00888867369856
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2025

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: FT STERNAL CLOSURE W/ TAPER CUTTING NDL
• Device Catalogue Number: AR-7288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 04/16/2025; 10/01/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/09/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown