NA 242073Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705031771), received between Mar 15, 2023 and Mar 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2023Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT DURING AN ANKLE SCOPE PROCEDURE ON (B)(6) 2023, THE SURGEON BENT A BUTTON OBTURATOR COMPATIBLE WITH 1.9 MM ENDOSCOPIC SYSTEM AND A BUTTON OBTURATOR COMPATIBLE WITH 2.7 MM ENDOSCOPIC SYSTEM. ACCORDING TO THE REPORT, THE DEVICES BENT ACCESSING THE JOINT IN A VERY TIGHT ANKLE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548606 ↗