Steel 88862393-69Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521102477), received between Aug 28, 2018 and Jul 25, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CARDIAC SURGERY, WHEN PLACING WIRES THROUGH THE CHEST TO CLOSE THE STERNUM, THE WIRE BROKE AND THE NEEDLE POPPED OFF THE WIRE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829528 ↗
• MalfunctionJul 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE, WHILE SUTURING, THE WIRES POPPED OFF THE NEEDLE, AND THE WIRE BROKE IN THE MIDDLE AS WELL. IT OCCURRED ON TWO SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827013 ↗
• MalfunctionJul 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE, WHILE SUTURING, THE WIRES POPPED OFF THE NEEDLE, AND THE WIRE BROKE IN THE MIDDLE AS WELL. IT OCCURRED ON TWO SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826994 ↗
• MalfunctionMay 6, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CARDIOVASCULAR CASE CLOSING WITH STERNAL WIRES, ON CLOSING WITH INTERRUPTED SUTURING TECHNIQUE, THE THREAD BROKE. THE SURGEON USED TWO MORE SUTURES TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248381 ↗
• MalfunctionNov 30, 2022Dull, Blunt; Detachment of Device or Device Component; Dull, Blunt; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN HEART SURGERY, THE NEEDLE BROKE FROM THE CONNECTION BETWEEN THE WIRE AND WOULD NOT PASS THROUGH TISSUE. THE SAME TYPE OF SUTURE BUT WITH A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887974 ↗
• MalfunctionJun 24, 2022Use of Device Problem; Detachment of Device or Device Component; Material Twisted/Bent; Use of Device Problem; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING STERNAL CLOSURE AFTER CORONARY ARTERY BYPASS GRAFT SURGERY, AT THE END OF THE PROCEDURE, BOTH THE NEEDLE AND THREAD BROKE. THE DEVICE WAS BENT FROM THE NEEDLE AND DID NOT PASS EASILY THROUGH THE STERNUM. TO RESOLVE THE ISSUE, TWONEW BAGS OF THE PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802319 ↗
• MalfunctionApr 6, 2021Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE WIRE DID NOT GO THROUGH THE STERNUM WELL. NEEDLES BENT AND NEEDED TO BE PASSED MULTIPLE TIMES FOR A SIMPLE WIRE RESULTING IN INCREASED BLEEDING AND MORE TIME SPENT ON PUTTING IN THE WIRES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 11618873 ↗
• MalfunctionMar 10, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING CLOSURE OF AN OPEN STERNAL PROCEDURE, THE THREE NEEDLES FREQUENTLY BENT WHEN GOING THROUGH STURDY STERNUM. ONE OF THESE BROKE. THE NEEDLES DID NOT APPEAR TO BE DULL, JUST THE STEEL WAS WEAK COMPARED TO NORMAL. ADDITIONAL SUTURES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453880 ↗
• MalfunctionMar 21, 2019Dull, Blunt; Detachment of Device or Device Component; Dull, Blunt; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN CORONARY ARTERY BYPASS PROCEDURE, WHILE CLOSING THE STERNUM, THE NEEDLE WAS NOT CUTTING ENOUGH. THE JUNCTURE OF NEEDLE AND THE STEEL WAS BROKEN. IT FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED. ANOTHER STEEL WAS USED ON THE PATIENT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8440268 ↗
• MalfunctionJan 10, 2019Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS SURGERY, THE NEEDLE AND THREAD BROKE. THE CONNECTION PORT OF THE NEEDLE WITH THE STEEL WIRE WAS BROKEN. ALSO THE NEEDLE WAS BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8237802 ↗
• MalfunctionJan 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING PROCEDURE, THE PORT OR THE CONNECTION POINT OF THE NEEDLE AND THE WIRE WAS SEPARATED FROM EACH OTHER ON THE STEEL WIRE. THE PRODUCT WAS REPLACED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8237780 ↗
• MalfunctionDec 21, 2018Difficult or Delayed Positioning; Material Twisted/Bent; Difficult or Delayed Positioning; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING PROCEDURE, THE NEEDLE WAS BECOMING CROOKED WHILE IN THE PROCESS, IT COULD NOT BE PASSED FROM THE BONE, AND IT WAS NOT ENOUGH FOR THE CLOSURE OF THE STERNUM. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. IT WAS ALSO REPORTED THAT THE INCISION WAS EXTENDED BY MORE THAN 1 INCH.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 8189181 ↗
• MalfunctionAug 28, 2018Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CORONARY ARTERY BYPASS GRAFTING, IN THE STERNUM WIRING PROCESS, THE NEEDLE WAS BENT. THE SAME PROBLEM WAS EXPERIENCED 3 TIMES WITH THE 3 DEVICES IN THE SAME CASE. THE STEEL WIRE COULD NOT SHOW ENOUGH RESISTANCE AND THE NEEDLES WERE BENT. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7822328 ↗