Steel 88862410-89Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521102590), received between Nov 6, 2018 and May 30, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE NEEDLE DETACHED WHILE PREPARING THE SUTURE AFTER A PATIENT INCISION. ANOTHER STERNAL WIRE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22120138 ↗
• MalfunctionMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE NEEDLE DETACHED WHILE PREPARING THE SUTURE AFTER A PATIENT INCISION. ANOTHER STERNAL WIRE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22120066 ↗
• MalfunctionApr 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER INTRAOPERATIVELY DURING CHEST CLOSURE WHILE THE SURGEON WAS PUTTING ON THE 3RD STERNAL WIRE OF A SET OF 4 PER PACK, THE NEEDLE CAME OFF FROM THE WIRE WHEN PULLED. A NEW SUTURE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21737195 ↗
• InjuryNov 27, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN-HEART CORONARY ARTERY BYPASS GRAFT, DURING THE STITCHING OF THE STERNUM, THE TWO SUTURES BROKE AND POST OPERATIVELY, THERE WAS A SEROSANGUINEOUS DRAINAGE FROM THE WOUND. SURGICAL TIME WAS EXTENDED FOR 60 MINUTES, AND THERE WAS A BLOOD LOSS OF MORE THAN 500CC. BLOOD TRANSFUSION WAS DONE AS A PRECAUTIONARY MEASURE. A NEW SUTURE FROM A DIFFERENT BOX WAS USED TO RESOLVE THE ISSUE. HOSPITALIZATION WAS EXTENDED FOR FIVE DAYS TO SEE IF THE STITCHING WAS INTACT AND DRAINAGE DID NOT OCCUR AGAIN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18213076 ↗
• InjuryNov 27, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN-HEART CORONARY ARTERY BYPASS GRAFT, DURING THE STITCHING OF THE STERNUM, THE TWO SUTURES BROKE AND POST OPERATIVELY, THERE WAS A SEROSANGUINEOUS DRAINAGE FROM THE WOUND. SURGICAL TIME WAS EXTENDED FOR 60 MINUTES, AND THERE WAS A BLOOD LOSS OF MORE THAN 500CC. BLOOD TRANSFUSION WAS DONE AS A PRECAUTIONARY MEASURE. A NEW SUTURE FROM A DIFFERENT BOX WAS USED TO RESOLVE THE ISSUE. HOSPITALIZATION WAS EXTENDED FOR FIVE DAYS TO SEE IF THE STITCHING WAS INTACT AND DRAINAGE DID NOT OCCUR AGAIN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18211879 ↗
• InjuryNov 20, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN HEART SURGERY FOR CORONARY ARTERY BYPASS GRAFTING (CABG), DURING STITCHING OF THE STERNUM, TWO SUTURES BROKE. AN X-RAY WAS PERFORMED, AND THERE WAS A BLOOD LOSS OF MORE THAN 500CC WHICH REQUIRED A BLOOD TRANSFUSION. THE SURGICAL TIME WAS EXTENDED AND LEAD TO PATIENT EXTEND HOSPITALIZATION FOR 2-4 DAYS. IT WAS NOTED THAT THERE WAS SEROSANGUINEOUS DRAINAGE FROM THE WOUND. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 18177026 ↗
• InjuryNov 20, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN HEART SURGERY FOR CORONARY ARTERY BYPASS GRAFTING (CABG), DURING STITCHING OF THE STERNUM, TWO SUTURES BROKE. AN X-RAY WAS PERFORMED, AND THERE WAS A BLOOD LOSS OF MORE THAN 500CC WHICH REQUIRED A BLOOD TRANSFUSION. THE SURGICAL TIME WAS EXTENDED AND LEAD TO PATIENT EXTEND HOSPITALIZATION FOR 2-4 DAYS. IT WAS NOTED THAT THERE WAS SEROSANGUINEOUS DRAINAGE FROM THE WOUND. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 18176908 ↗
• MalfunctionNov 6, 2018Break; Break

  ACCORDING TO THE REPORTER, AT THE TIME OF SUTURING THE EXTERNUM DURING AN OPEN CARDIOVASCULAR SURGERY, THE NEEDLE BROKE. THEY NOTED THAT THE SURGEON WAS USING A CONTINUOUS TECHNIQUE IN SUTURING. THEY USED A NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8041566 ↗