NA 03.211.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982076106), received between Aug 27, 2024 and Aug 29, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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 18, 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 29, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AUGUST 1, 2024, THE DEVICES WERE DULL. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED REAMER PROXIMAL/14MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20102164 ↗
• MalfunctionAug 27, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DEVICES WERE DULL. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) CANNULATED REAMER DISTAL/14MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078758 ↗