MAUDE Adverse Event Report: CIRCUMFIX SOLUTIONS INC VARITRAX STERNAL CIRCUMFIXATOR¿ SYSTEM; VARITRAX STERNAL CIRCUMFIXATOR¿ SET

Model Number	CFSK-0166
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's physical condition, advanced coronary artery disease, diabetes, morbid obesity, likely contributed to the issue.
Event or Problem Description
Approximately 10 month after initial surgery (initial surgery date (b)(6) 2025), the patient returned complaining of chest wall pain.Surgical team exam determined non-union of sternum.Revision surgery was performed and discovered that bands were broke.Device was removed and device from a different manufacturer was implanted.

• Brand Name: VARITRAX STERNAL CIRCUMFIXATOR¿ SYSTEM
• Common Device Name: VARITRAX STERNAL CIRCUMFIXATOR¿ SET
• Manufacturer (Section D): CIRCUMFIX SOLUTIONS INC; 224 grand steeple drive; collierville TN 38017
• Manufacturer Contact: louis houff ; 224 grand steeple drive; collierville, TN 38017
• MDR Report Key: 24413674
• Report Number: 3027404764-2026-00001
• Device Sequence Number: 14922578
• Product Code: JDQ
• UDI-Device Identifier: 00850049938037
• UDI-Public: 00850049938037
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K232986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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 Expiration Date: 05/22/2026
• Device Model Number: CFSK-0166
• Device Lot Number: 142-25-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 137 KG