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

Model Number	TIGERTAPE STERNAL CLOSURE W/ CUTTING NDL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); 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 march of 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.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 3/14/2025, 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: 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 can be misuse due to a patient-specific event.

• Brand Name: TIGERTAPE STERNAL CLOSURE W/ 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: 21993373
• Report Number: 1220246-2025-01961
• Device Sequence Number: 14572275
• Product Code: GAT
• UDI-Device Identifier: 00888867369863
• UDI-Public: 00888867369863
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• 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/ CUTTING NDL
• Device Catalogue Number: AR-7288T
• 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: 05/09/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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