NA 03.211.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982076151), received between Dec 23, 2021 and Dec 23, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT FOLLOWING A PROCEDURE ON (B)(6) 2021, THE CANNULATED FOOT REAMERS WERE BLUNT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CANNULATED REAMER. THIS IS REPORT 15 OF 20 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13081617 ↗
• MalfunctionDec 23, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT FOLLOWING A PROCEDURE ON (B)(6) 2021, THE CANNULATED FOOT REAMERS WERE BLUNT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CANNULATED REAMER. THIS IS REPORT 13 OF 20 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13081391 ↗
• MalfunctionDec 23, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT FOLLOWING A PROCEDURE ON (B)(6) 2021, THE CANNULATED FOOT REAMERS WERE BLUNT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CANNULATED REAMER. THIS IS REPORT 4 OF 20 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080299 ↗