Steel 88862414-89Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521102620), received between Jun 11, 2020 and Oct 11, 2024 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CARDIAC SURGERY PROCEDURE, THE NEEDLE DETACHES FROM THE THREAD WHEN THE SURGEON STRETCHES IT TO PLACE IT, NOT ALLOWING IT TO PASS THROUGH THE THICKNESS OF THE STERNUM. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428784 ↗
• MalfunctionOct 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A CARDIAC SURGERY PROCEDURE, THE NEEDLE DETACHES FROM THE THREAD WHEN THE SURGEON STRETCHES IT TO PLACE IT. NOT ALLOWING IT TO PASS THROUGH THE THICKNESS OF THE STERNUM. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20420974 ↗
• MalfunctionJun 27, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CARDIAC SURGERY, WHILE SUTURING AFTER THE INCISION, THE STEEL THREAD OF THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19626164 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING (CABG), BLOOD WAS OOZING OUT FROM SURROUNDING WHEN STITCHING THE CHEST CAVITY FROM ALL 5 SUTURES. THERE WAS BLOOD LOSS OF MORE THAN 500CC DUE TO THE ISSUE. THE PATIENT HAD TO BE RE-OPERATED WITH A DIFFERENT COMPANY'S SUTURE TO RESOLVE THE ISSUE. THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE DUE TO THE ISSUE. THE PATIENT HOSPITALIZATION WAS EXTENDED 2 DAYS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 19147440 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING (CABG), BLOOD WAS OOZING OUT FROM SURROUNDING WHEN STITCHING THE CHEST CAVITY FROM ALL 5 SUTURES. THERE WAS BLOOD LOSS OF MORE THAN 500CC DUE TO THE ISSUE. THE PATIENT HAD TO BE RE-OPERATED WITH A DIFFERENT COMPANY'S SUTURE TO RESOLVE THE ISSUE. THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE DUE TO THE ISSUE. THE PATIENT HOSPITALIZATION WAS EXTENDED 2 DAYS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 19147328 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING (CABG), BLOOD WAS OOZING OUT FROM SURROUNDING WHEN STITCHING THE CHEST CAVITY FROM ALL 5 SUTURES. THERE WAS BLOOD LOSS OF MORE THAN 500CC DUE TO THE ISSUE. THE PATIENT HAD TO BE RE-OPERATED WITH A DIFFERENT COMPANY'S SUTURE TO RESOLVE THE ISSUE. THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE DUE TO THE ISSUE. THE PATIENT HOSPITALIZATION WAS EXTENDED 2 DAYS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 19147305 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING (CABG), BLOOD WAS OOZING OUT FROM SURROUNDING WHEN STITCHING THE CHEST CAVITY FROM ALL 5 SUTURES. THERE WAS BLOOD LOSS OF MORE THAN 500CC DUE TO THE ISSUE. THE PATIENT HAD TO BE RE-OPERATED WITH A DIFFERENT COMPANY'S SUTURE TO RESOLVE THE ISSUE. THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE DUE TO THE ISSUE. THE PATIENT HOSPITALIZATION WAS EXTENDED 2 DAYS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 19147030 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING (CABG), BLOOD WAS OOZING OUT FROM SURROUNDING WHEN STITCHING THE CHEST CAVITY FROM ALL 5 SUTURES. THERE WAS BLOOD LOSS OF MORE THAN 500CC DUE TO THE ISSUE. THE PATIENT HAD TO BE RE-OPERATED WITH A DIFFERENT COMPANY'S SUTURE TO RESOLVE THE ISSUE. THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE DUE TO THE ISSUE. THE PATIENT HOSPITALIZATION WAS EXTENDED 2 DAYS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 19146897 ↗
• MalfunctionApr 10, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE REPAIR OF A RUPTURED AORTIC SINUS ANEURYSM AND PATENT FORAMEN OVALE ON THE PATIENT, THE STAINLESS STEEL SUTURE WAS FOUND TO BE BROKEN WHEN THE CHEST WAS CLOSED ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. A REVIEW OF THE X-RAY ON THE SECOND DAY AFTER THE SURGERY SHOWED THAT THERE WERE MULTIPLE OVERLAPPING INTERNAL FIXATION SHADOW ON THE STERNUM, AND A RING-SHAPED SHADOW WAS NOT CLOSED WHICH SHOWED THAT THE SUTURE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 19080700 ↗
• MalfunctionNov 9, 2023Break; Break

  ACCORDING TO THE REPORTER, MORE THAN A YEAR POST-OPERATIVE A OPEN REDUCTION AND INTERNAL FIXATION OF PATELLAR FRACTURE, UPON RE-EXAM INATION FOR THE PLANNED REMOVAL OF SUTURE IT WAS FOUND THAT THE SUTURE WAS BROKEN. THE SURGEON CONSIDERED THAT THE FRACTURE HEALING WAS ACCEPTABLE AND THE DEVICE WAS SURGICALLY REMOVED AND A ROUTINE IMAGING DIAGNOSIS WAS CONFIRMED DURING SURGERY.

  Patient problems: Tissue Breakdown

  MAUDE report 18104302 ↗
• MalfunctionMay 3, 2021Dull, Blunt; Dull, Blunt

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE WIRE WAS NOT CUTTING WELL THROUGH STERNUM AND WAS BLUNT. IT WAS STATED THAT IT WAS DIFFICULT AND DULL TO DRIVE THROUGH TISSUE. IT WAS REQUIRED TO PUSH THE NEEDLE THROUGH. THE PRODUCT WAS CHANGED. IT WAS STATED THAT SURGICAL TIME WAS EXTENDED TO 30 MINUTES OR MORE DUE TO THE DEVICE'S ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766664 ↗
• MalfunctionJun 11, 2020Break; Dull, Blunt; Break; Dull, Blunt

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN CLOSING THE STERNUM, THE NEEDLE WAS NOT SHARP ENOUGH AND COULD BE EASILY BROKEN. TO RESOLVE THE ISSUE THE SURGEON OPENED A NEW PACKAGE OF EQUIPMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143539 ↗