NA 351.94Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982194077), received between Oct 16, 2019 and Aug 1, 2025 — classified as 2 malfunctions.

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

• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE; AT THE TIME OF ITS MANIPULATION THE MANUAL CUTTER WAS BROKEN. A PROMPT SOLUTION WAS GIVEN TO THE DOCTOR USING ANOTHER MANUAL CUTTER OF ANOTHER MEASURE, THUS ACHIEVING TO FINISH THE SURGERY SUCCESSFULLY WITHOUT ANY DISCOMFORT OF THE SPECIALIST. FOR THE ABOVE MENTIONED THERE WERE NO AFFECTATIONS TO THE PATIENT, NOR ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686859 ↗
• MalfunctionOct 16, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, WHILE PUTTING THE SETS BACK TOGETHER AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THE HANDLES OF THE TWO (2) HAND HELD REAMERS WERE BROKEN OFF AND NO LONGER USABLE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) HAND-REAMER F/MEDULL-CANAL Ø8. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197837 ↗