Sheehy 1156363Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00681490035736), received between Apr 24, 2019 and May 3, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMay 3, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE PROSTHESIS BROKE OFF AND DETACHED DURING AN OSSICULAR RECONSTRUCTION PROCEDURE WITHOUT EXCESS FORCE. THE PROSTHESIS WAS OPERATED WITH AN ALLIGATOR FORCEPS. THIS WAS THE FIRST TIME THE DEVICE WAS USED. THERE WAS NO INTERVENTION PLANNED AND PERFORMED. THERE WAS A DELAY OF ABOUT 5-8 MINUTES. THERE WAS NO BROKEN PIECES LEFT/REMAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH BACK UP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577647 ↗
• MalfunctionApr 24, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) VIA A DISTRIBUTOR REPORTED THAT A PROSTHESIS BROKE INTO TWO PIECES DURING OSSICULAR RECONSTRUCTION SURGERY. THE HCP MADE SURE THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT'S BODY AND NOTED THAT THE DEVICE WAS HANDLED GENTLY WITHOUT IMPROPER FORCE. THE PROCEDURE WAS COMPLETED USING A BACK-UP PRODUCT. THERE WAS A PROCEDURE DELAY OF 10 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8547537 ↗