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 Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Purulent Discharge (1812); Erythema (1840); Wound Infection (2447)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 4/9/2025, an fda medwatch notification was received via email.A facility representative reported that a patient underwent mechanical aortic valve replacement, a mechanical mitral valve replacement, and a coronary artery bypass graft procedure in (b)(6) 2025.The patient's sternal closure was achieved with an ar-7288 fibertape sternal closure and ar-7288t fibertape sternal closure system.The patient then presented with a sternal wound infection.The patient underwent surgical irrigation and debridement.The surgical cultures revealed corynebacterium amycolatum.No further information was provided.Additional information was requested on 4/10/2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 4/16/2025: the initial surgery took place on (b)(6) 2025, during which an ar-7288 fibertape sternal closure, an ar-7288t fibertape sternal closure, and an ar-7289t tigertape sternal closure were implanted.Around (b)(6) 2025, the patient developed purulent drainage and erythema at the chest incision site.The infection was managed with iv antibiotics, multiple irrigation and debridement procedures, wound vacuum-assisted closures, and a pectoral flap for chest closure.The patient underwent procedures on (b)(6) 2025 to address the ongoing infection.During a subsequent surgical intervention, the ar-7288 fibertape sternal closure and ar-7289t tigertape sternal closure were explanted.As of (b)(6) 2025, the patient remains hospitalized and continues receiving iv vancomycin.
Additional Manufacturer Narrative
Additional information: d6a, 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 for the reported failure can be attributed 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: 21912893
• Report Number: 1220246-2025-01761
• Device Sequence Number: 7135860
• Product Code: GAT
• UDI-Device Identifier: 00888867369856
• UDI-Public: (01)00888867369856(11)250128(17)291231(10)15379663
• 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
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2025

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
• Device Lot Number: 15379663
• 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: Not provided; 10/08/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/20/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• 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