MAUDE Adverse Event Report: ARTHREX, INC. TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL; FIXATION CERCLAGE

Model Number	TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	03/10/2025
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 a coronary artery bypass graft procedure in (b)(6) 2025.The patient's sternal closure was achieved with an ar-7288 fibertape sternal closure system.The patient then presented with a sternal wound infection, requiring additional surgery.Surgical cultures revealed corynebacterium amycolatum.No additional information was provided.Additional information was received on 4/16/2025: the initial surgery took place on (b)(6) 2025, during which four ar-7289t and three ar-7288 implants were placed.Around (b)(6) 2025, the patient began experiencing sternal wound redness, purulent drainage, and invasive fungal disease.To address these complications, the patient underwent multiple irrigation and debridement procedures on (b)(6) 2025, followed by bilateral pectoralis advancement flaps for chest closure.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 readmitted on (b)(6) 2025 for a current sternal wound infection.
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 for the reported failure can be attributed to a patient-specific event.

• Brand Name: TIGERTAPE STERNAL CLOSURE W/ BLUNT 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: 22005281
• Report Number: 1220246-2025-02007
• Device Sequence Number: 18441993
• Product Code: GAT
• UDI-Device Identifier: 00888867369887
• UDI-Public: (01)00888867369887(11)250116(17)291231(10)15373984
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL
• Device Catalogue Number: AR-7289T
• Device Lot Number: 15373984
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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