Sternal Cable System 400-689Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846468040895), received between Mar 10, 2017 and Sep 23, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2021Break; Break

  ON 8/25/2021 IT WAS REPORTED TO PIONEER SURGICAL TECHNOLOGY THAT "A PATIENT, CALLED IN STATING HE HAS A BROKEN WIRE IN HIS CHEST. HE FOUND THIS OUT AT A DR APPT ON (B)(6) 2021. ORIGINAL DATE OF SURGERY WAS (B)(6) 2019 AT (B)(6). HE HAS BEEN TOLD BY HIS SURGEON THAT HE IS GOING TO HAVE TO HAVE ANOTHER SURGERY TO REPLACE THE BROKEN WIRE."

  Patient problems: Insufficient Information

  MAUDE report 12521248 ↗
• InjuryMar 10, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED FROM THE COUNTRY OF (B)(6) THAT A PATIENT HAD EXPERIENCED INFECTION AFTER A SURGERY USING PIONEER SURGICAL TECHNOLOGY STERNAL CABLE SYSTEM. NO MORE INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 6397362 ↗
• InjuryMar 10, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED FROM THE COUNTRY OF (B)(6) THAT A PATIENT HAD EXPERIENCED INFECTION AFTER A SURGERY USING (B)(4) STERNAL CABLE SYSTEM. NO MORE INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 6397355 ↗
• InjuryMar 10, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED FROM THE COUNTRY OF (B)(6) THAT A PATIENT HAD EXPERIENCED INFECTION AFTER A SURGERY USING PIONEER SURGICAL TECHNOLOGY STERNAL CABLE SYSTEM. NO MORE INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 6397354 ↗