NA 3819Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010118882), received between Feb 2, 2018 and Feb 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT WHILE UTILIZING ABRADER 3.5MM (C/N: (B)(4)), IT WAS CONFIRMED THAT THE ROTATION SPEED WAS SLOWED EVEN THOUGH THE SURGEON HAD SET THE MAXIMUM RPM SETTING. THEY COULDN¿T RESECT THE PATIENT BONE AND THE ROTATION OF BLADE COULD BE VISIBLE BY THE NAKED EYE. THEY TRIED TO REBOOT THE CONTROL UNIT AND RECONNECTED THE BLADE TO THE HAND-PIECE, HOWEVER THE PROBLEM COULDN¿T BE RESOLVED. THEY STOPPED TO RESECT THE PATIENT BONE AND THE PROCEDURE WAS FINISHED ONLY RESECTION OF THE SYNOVIAL TISSUE. THERE WAS A 10 MINUTES DELAY IN THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7238834 ↗