STERNALOCK® BLU SYSTEM 73-2418 (UDI 00888233000918)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888233000918), received between Sep 8, 2022 and Sep 2, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K110574, K121302, K161896); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Fracture

  Patient problems: Insufficient Information

  MAUDE report 50569111 ↗
• MalfunctionMay 19, 2026Fracture

  IT WAS REPORTED THAT DURING STERNAL CLOSURE, WHILE INSERTING 18-MM SCREWS WITH A POWER DRIVER, THE HEAD OF ONE SCREW FRACTURED OFF, AND A SECOND SCREW COULD NOT BE INSERTED AS IT WOULD NOT PENETRATE THE BONE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25223324 ↗
• InjurySep 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THAT ONE SCREW FROM A 4-PACK WAS INSERTED WITH A CORDLESS SCREWDRIVER AS THE 31ST OF A TOTAL OF 32 SCREWS. THE SCREW FRACTURED OFF BEFORE IT COULD BE FULLY COUNTERSUNK INTO THE STERNUM. THE SCREW HEAD FRACTURED LEAVING THE THREADED PART IN THE PATIENT'S STERNUM. THE OTHER THREE (3) SCREWS OF THIS 4-PACK WERE PREVIOUSLY USED WITH THE PATIENT WITH NO ISSUES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15379271 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110574, K121302, K161896. One submission often covers many models, so check the product and lot details in each record.

• Z-0843-2012 · Nov 23, 2011 · Terminated
  The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades. The SternaLock Blu Implant Tray would have been found within the following outer cont