Steel 88862392-49Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521102453), received between Mar 22, 2019 and Sep 19, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2019Dull, Blunt; Detachment of Device or Device Component; Dull, Blunt; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DID NOT PENETRATE THE STERNUM AND THE NEEDLE DETACHED. A MEDICAL INTERVENTION WAS NEEDED OR PREVENT PERMANENT IMPAIRMENT. IT WAS STATED THAT THE EVENT RESULTED TO UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9088661 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ATRIAL PROCEDURE, WHEN THEY STITCHED THE STERNUM, THE FIVE NEEDLES AND THREADS' CONNECTION PART WERE BROKEN AND THEY WERE DISENGAGED. THEY USED ANOTHER THREAD TO PERFORM THE SUTURE.THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8443555 ↗