STERNALOCK® BLU SYSTEM 73-2414 (UDI 00841036141158)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00841036141158), received between Apr 4, 2019 and Nov 4, 2020 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THE STERNAL SCREW STRIPPED EASILY UPON INSERTION DURING A PRIMARY STERNOTOMY. WHEN THE SCREW WAS BEING TIGHTENED WITH A MANUAL DRIVER, THE SCREW STRIPPED EASILY AND DEFORMED THE SCREW HEAD. THE SCREW HEAD WAS REMOVED USING A CHISEL AND MALLET WHILE THE SCREW BODY WAS REMOVED USING PICK-UPS. THE SCREW WAS REPLACED WITH A DIFFERENT SCREW ONE SIZE SMALLER. THE MALFUNCTION RESULTED IN A FIVE (5) MINUTE SURGICAL DELAY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10785882 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 10645020 ↗
• InjuryAug 11, 2020Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Wound Dehiscence

  MAUDE report 10391410 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10359256 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10212710 ↗
• InjuryMar 18, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9849000 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN EMERGENT RE-ENTRY DUE TO AN UNKNOWN REASON. STERNAL PLATES AND SCREWS WERE REMOVED AND THE PATIENT WAS CLOSED WITH NEW STERNAL PLATES AND SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9547024 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN EMERGENT RE-ENTRY DUE TO BLEEDING. THE PATIENT WAS CLOSED WITH NEW STERNAL PLATES AND SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9540128 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT INDICATED THE RE-OPERATION WAS PERFORMED DUE TO BLEEDING AND WAS NOT IN ANY WAY RELATED TO A DEVICE PROBLEM. THIS IS NOT A REPORTABLE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9513376 ↗
• InjuryNov 27, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Code Available

  MAUDE report 9386761 ↗
• InjurySep 5, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Injury; No Patient Involvement

  MAUDE report 8968050 ↗
• InjuryJul 18, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8805778 ↗
• InjuryJun 21, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BYPASS SURGERY IN 2016. THE STERNLOCK PRODUCT WAS IMPLANTED IN SPRING/SUMMER 2017 AFTER A STERNAL WOUND HEALING DISORDER. AFTER APPROXIMATELY TWO YEARS, IMAGING SHOWED TRANSVERSE FRACTURES AND DEHISCENCE AT THE MANUBRIUM/XIPHOID. UPON REMOVAL OF THE PRODUCT, THREE SCREWS WERE FRACTURED AT THE LOWER THREADS. THE LOWER PART OF THE THREADS WERE NOT REMOVED FROM THE PATIENT'S BONE.

  Patient problems: Bone Fracture(s); Organ Dehiscence

  MAUDE report 8723529 ↗
• MalfunctionMay 10, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE SCREW HEAD DID NOT RETAIN ON THE BLADE ADEQUATELY. THEREFORE, THE SCREW COULD NOT BE INSERTED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601327 ↗
• InjuryApr 4, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO THE SCREWS PULLING OUT OF THE BONE RESULTING IN STERNAL SEPARATION. THE PATIENT'S STERNUM WAS ORIGINALLY CLOSED WITH WIRE AFTER A CARDIAC SURGERY APPROXIMATELY TWO MONTHS PRIOR TO IMPLANTATION OF STERNALOCK. THE WIRES FAILED AND STERNALOCK WAS IMPLANTED AS A RESULT. THE PATIENT REPORTED THAT HE FELT PAIN AND INSTABILITY WHILE AT A GUN RANGE AND IT WAS DETERMINED VIA X-RAY THAT THE SCREWS HAD PULLED AWAY FROM THE STERNUM ON ONE SIDE. SUBSEQUENTLY, ALL STERNLOCK PLATES AND SCREWS WERE REMOVED. THE SURGEON ADVISED THAT HE DOES NOT BELIEVE THAT THIS ISSUE WAS RELATED TO THE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8483815 ↗

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