Sternal Cable System 400-425Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846468040758), received between Mar 11, 2020 and Mar 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2020Break; Material Fragmentation; Break; Material Fragmentation

  DURING A ROUTINE MAUDE SEARCH CONDUCTED BY RTI SURGICAL, IT WAS IDENTIFIED THAT AN ADVERSE EVENT HAD TAKEN PLACE AND THE HOSPITAL FILED A REPORT WITH THE FDA. THE HOSPITAL DID NOT NOTIFY ITS DISTRIBUTOR OF THIS OCCURRENCE, THEREFORE, RTI SURGICAL WAS ALSO NOT NOTIFIED. THE EVENT DESCRIPTION PROVIDED IN THE MAUDE STATES THE FOLLOWING, "A (B)(6) MALE PRESENTED FOR A CABG X 5 DUE TO OUTPATIENT WORKUP DEMONSTRATING MULTIVESSEL. CAD. THE PROCEDURE WAS PERFORMED SUCCESSFULLY AND THE SURGEON BEGAN CLOSURE OF THE STERNUM. UPON IMPLANTATION OF CABLE INTO THE STERNUM, A SMALL PORTION OF THE STERNAL CABLE SYSTEM BROKE OFF INTO THE STERNUM. AN INTRAOPERATIVE X-RAY WAS TAKEN THAT SHOWED A RADIOPAQUE FOREIGN BODY SUGGESTIVE OF THE KNOWN FRACTURED NEEDLE STUCK IN THE PT'S STERNUM. UPON ASSESSMENT THE SURGEON DETERMINED THAT IT WOULD BE MORE HARMFUL TO ATTEMPT TO REMOVE THE METAL THAN TO KEEP IT IN PLACE. THE STERNAL EDGES WERE THEN CLOSED USING THE CABLES AND THE WOUND WAS CLOSED. THE PT TOLERATED THE PROCEDURE WELL AND WAS ADMITTED AS PER PRE-HOSPITAL PLAN. NO FURTHER ISSUES DUE TO BROKEN ITEM. PT WAS ABLE TO BE DISCHARGED HOME ON 04/22 WITH PLANS TO F/U AS AN OUTPATIENT."

  Patient problems: No Code Available

  MAUDE report 9817343 ↗