NA 389.56Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034775982), received between Apr 4, 2025 and Mar 9, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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. 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.

• MalfunctionMar 9, 2026Mechanical Problem; Compatibility Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT HANDLE WAS LOOSE AND UNABLE TO TIGHTEN. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543653 ↗
• MalfunctionApr 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SURGEON WENT TO DISSECT AND THE HANDLE CRUMBLED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772659 ↗