Steel 88862222-69Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521102330), received between Nov 1, 2017 and Sep 6, 2023 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING AN ANTERIOR INTERVENTRICULAR CORONARY ARTERY BYPASS GRAFTING, THE SURGEON NOTICED THAT THE STEEL WIRES WERE BREAKING WHILE THE WIRE WAS BEING TIGHTENED. IT WAS ALSO NOTED THAT THE WIRE APPEARED TO BE MORE FRAGILE IN THE CRIMPING AREA. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17691262 ↗
• MalfunctionSep 6, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, THE SURGEON NOTICED THAT THE STEEL WIRES WERE BREAKING WHILE THE WIRE WAS BEING TIGHTENED. IT WAS ALSO NOTED THAT THE WIRE APPEARED TO BE MORE FRAGILE IN THE CRIMPING AREA.

  Patient problems: Insufficient Information

  MAUDE report 17691108 ↗
• InjuryJan 15, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, WHEN THE STERNUM WAS CLOSED DURING A MYOCARDIAL REVASCULARIZATION, THREE SUTURES DISLODGED. THERE WAS TISSUE DAMAGE AS A RESULT OF THIS PROBLEM.

  Patient problems: Tissue Damage

  MAUDE report 9590661 ↗
• MalfunctionJun 12, 2018Break; Break

  ACCORDING TO THE REPORTER, WHILE TRYING TO CLOSE A STERNUM USING A CLASSIC SUTURING TECHNIQUE DURING AN OPEN CARDIAC SURGERY, THE NEEDLE BROKE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7592063 ↗
• MalfunctionApr 5, 2018Difficult To Position; Difficult To Position

  ACCORDING TO THE REPORTER, DURING A CARDIAC SURGERY, WHEN THEY WERE USING STEEL WIRES TO CLOSE THE STERNUM OF PATIENT, THE NEEDLE LOOSENED. THEY USED ANOTHER PRODUCT TO COMPLETE THE CASE. PATIENT STATUS WAS ASKED BUT UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7399894 ↗
• MalfunctionNov 1, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN VALVE REPLACEMENT PROCEDURE. THE SUTURE WAS NOT TREATED OR HYDRATED PRIOR TO USE. THE NEEDLE DETACHED FROM THE THREAD WHEN EMPLOYING A NORMAL SUTURING TECHNIQUE DURING STERNUM CLOSURE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, AN ADDITIONAL SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6994406 ↗