Steel 88862410-69Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10884521102576), received between Mar 6, 2018 and Apr 11, 2026 — classified as 5 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HEART VALVE PROCEDURE, WHILE SUTURING, THE SUTURE DETACHED FROM THE NEEDLE. THE PROCESS WAS COMPLETED USING THE SAME PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847343 ↗
• MalfunctionSep 10, 2025Dull, Blunt; Detachment of Device or Device Component; Dull, Blunt; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT (CABG), DURING STERNAL CLOSURE, THE NEEDLE WAS DETACHED AND MULTIPLE COMPLAINTS ABOUT NEEDLES BEING DULL OUT OF PACK. IT WAS ALSO NOTED THAT THERE WAS DIFFICULTY PASSING THE NEEDLES THROUGH THE INTERCOSTAL SPACE. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM A DIFFERENT MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012681 ↗
• MalfunctionSep 10, 2025Dull, Blunt; Detachment of Device or Device Component; Dull, Blunt; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT (CABG), DURING STERNAL CLOSURE, THE NEEDLE WAS DETACHED AND MULTIPLE COMPLAINTS ABOUT NEEDLES BEING DULL OUT OF PACK. IT WAS ALSO NOTED THAT THERE WAS DIFFICULTY PASSING THE NEEDLES THROUGH THE INTERCOSTAL SPACE. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM A DIFFERENT MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012664 ↗
• MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STERNUM WIRE BROKE FROM THE NEEDLE JUNCTION. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19630058 ↗
• MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A STERNA PROCEDURE, THE STERNUM WIRE BROKE FROM THE NEEDLE JUNCTION. THE SURGICAL TIME WAS EXTENDED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625676 ↗
• MalfunctionMay 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE WHEN CLOSING THE STERNUM LINE, THE NEEDLE DETACHED FROM THE THREAD AT THE SWAGE. THIS CAUSED A 5 MINUTES DELAY IN THE PROCEDURE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17023012 ↗
• MalfunctionMar 6, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN OPEN BYPASS PROCEDURE, WHEN CLOSING THE THORAX, THE NEEDLE WAS SEPARATED FROM THE STEEL FOR THE NINE NON-ABSORBABLE SUTURES. THERE WAS TISSUE DAMAGE AND IT WAS MULTI-PASSING ON THE TISSUE. THE SURGICAL TIME WAS EXTENDED BY FIFTEEN MINUTES DUE TO THE PRODUCT PROBLEM. MORE SUTURING WAS DONE USING ANOTHER SUTURE TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16489942 ↗
• InjuryJan 10, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN BYPASS PROCEDURE, WHEN CLOSING THE THORAX, THE NEEDLE WAS SEPARATED FROM THE STEEL FOR THE 9 NON-ABSORBABLE SUTURES. THERE WAS TISSUE DAMAGE AND IT WAS MULTI-PASSING ON THE TISSUE. THE SURGICAL TIME WAS EXTENDED BY FIFTEEN MINUTES DUE TO THE PRODUCT PROBLEM. MORE SUTURING WAS DONE USING ANOTHER SUTURE TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16132953 ↗
• MalfunctionJan 13, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT PROCEDURE, WHILE CLOSING STERNOTOMY WITH STEEL USING CONTINUOUS TECHNIQUE, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254350 ↗
• MalfunctionJun 15, 2021Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE OF THE SUTURE BROKE DURING STERNUM CLOSURE. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005808 ↗
• MalfunctionJun 15, 2021Break; Break

  ACCORDING TO THE REPORTER, WHEN THE STERNUM WAS BEING CLOSED DURING AN OPEN MITRAL VALVE REPLACEMENT, THE NEEDLE BROKE. A COMPETITOR¿S DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005731 ↗
• InjurySep 15, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING PROCEDURE, WHILE CLOSING THE STERNUM, THE STERNUM WIRE BREAKS AT THE NEEDLE CONNECTION POINT AND OVER THE WIRE. IT WAS ALSO REPORTED THAT THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE DUE TO THE REPORTED EVENT. THE STERNUM BONE WAS INJURED AND 4 MORE SUTURES WERE OPENED BUT WERE ALSO BROKEN.

  Patient problems: No Code Available; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 10536067 ↗
• MalfunctionJun 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS GRAFT, AT THE NEAR END OF THE PROCEDURE WHILE CLOSING THE WOUND, NEEDLE DETACHED FROM THE THREAD, BEFORE USING IT. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 10 MINUTES DUE TO THE DEVICE PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10180855 ↗
• MalfunctionMar 17, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSURE OF STERNUM IN REPLACEMENT OF AN AORTIC VALVE OPEN PROCEDURE, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842466 ↗
• MalfunctionMar 11, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING MITRAL PLASTY AND CORONARY BYPASS PROCEDURE, WHILE THE SURGEON PERFORMED STERNAL SUTURING, THE DEVICE STEEL WIRE LOOSENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9819190 ↗
• MalfunctionMar 11, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING STERNAL SUTURING ON A MITRAL PLASTY, THE STEEL WIRES BROKE WHEN STITCHES WERE MADE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9817453 ↗
• MalfunctionFeb 12, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THORACIC STERNAL CLOSURE, BOTH NEEDLE AND THREAD BROKE. THE NEEDLE DROP OFF DURING THE CLOSURE SO THE PRODUCT WAS NOT USED IN PATIENT. ANOTHER PRODUCT FROM ANOTHER SERIAL NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9699973 ↗
• MalfunctionJan 20, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE CLOSURE OF THE STERNUM IN AN OPEN STERNOTOMY PROCEDURE, THE SUTURE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 9606494 ↗
• InjuryOct 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN REPLACING THE MITRAL VALVE AND AORTIC VALVE, THE STEEL WIRES DISLODGED FROM THE NEEDLE WHEN CLOSING THE STERNUM. THIS RESULTED TO STERNAL HEMOSTASIS AND SLIGHT DELAY IN THE OPERATION.

  Patient problems: Hemostasis

  MAUDE report 9187893 ↗
• InjuryOct 11, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, AT THE END OF THE PROCEDURE FOR CORONARY BYPASS, THE STEEL WIRES LOOSEN WHEN USED TO CLOSE THE STERNUM. THERE WAS AN EXTENSION OF THE INTERVENTION PERIOD AND A DIFFICULTY OF STERNAL CLOSURE. THERE WAS AN ADDITIONAL HEMOSTASIS OF THE STERNAL WOUND. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: Hemostasis

  MAUDE report 9182492 ↗
• MalfunctionSep 19, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN VALVULAR REPLACEMENT PROCEDURE, THE DEVICE NEEDLE AND THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088404 ↗
• MalfunctionSep 19, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN VALVULAR REPLACEMENT PROCEDURE, THE NEEDLE BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088364 ↗
• MalfunctionSep 19, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN VALVULAR REPLACEMENT PROCEDURE, THE NEEDLE BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088341 ↗
• InjuryOct 16, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE PART OF THE SUTURE WAS BROKEN AND FELL INTO THE CAVITY OF THE PATIENT. AN X-RAY WAS PERFORMED FOR THE PURPOSE OF LOCATING THE NEEDLE AND THE NEEDLE WAS RETRIEVED. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 7969412 ↗
• MalfunctionMar 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING STERNUM CLOSURE. THE DEVICE BROKE AT THE SWAGE OF THE NEEDLE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316650 ↗