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 a coronary artery bypass graft procedure on (b)(6) 2025, during which a fibertape sternal closure was used.The patient then presented with a corynebacterium amycolatum sternal wound infection, requiring additional surgery.No further information was provided.Additional information received on 4/16/2025: the patient underwent initial surgery on (b)(6) 2025, during which an ar-7288 fibertape sternal closure, an ar-7289t tigertape sternal closure, and an ar-7288t tigertape sternal closure were implanted.Postoperatively, on (b)(6) 2025, the patient developed sternal wound drainage, gas accumulation, and fluid collection extending to the mediastinum.To address these complications, the patient required multiple irrigation and debridement procedures, along with wound vacuum-assisted closures, performed on (b)(6) 2025.Following these interventions, the patient underwent a bilateral pectoralis flap procedure 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.Additional information requested on 5/12/2025.
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 for the reported failure can be attributed 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: 22004280
• Report Number: 1220246-2025-02003
• Device Sequence Number: 9201763
• Product Code: GAT
• UDI-Device Identifier: 00888867369863
• UDI-Public: (01)00888867369863(11)250107(17)291231(10)15369809
• 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
• 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
• Device Lot Number: 15369809
• 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): No
• Date Device Manufactured: 01/07/2025
• 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