NA 2001-80-503Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295080169), received between Jun 1, 2018 and Jun 28, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2021Break; Break

  IT WAS REPORTED THAT THE DOCTOR WENT TO PLANE THE CALCAR, WHEN HE PULLED THE CALCAR PLANER OFF, THERE WAS A CENTER HUB THAT CAME OFF THE PLANER. THE DOCTOR PULLED THE PIECE OFF THE BROACH AND CONTINUED WITH THE CASE. THE PIECE WAS RETRIEVED. THERE WAS NO DELAY IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080693 ↗
• MalfunctionAug 22, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE AML CALCAREOUS PLANERS ARE DULL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806264 ↗
• MalfunctionJun 1, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE AML LARGE CALCAR PLANER IS DULL. SURGICAL DELAY OF 3 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 7562629 ↗