NA 03.211.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982076120), received between Dec 23, 2021 and Sep 9, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE CUP AND CONE REAMERS WERE NO LONGER SHARP FOR MTP FUSION JOINT PREP.

  Patient problems: Insufficient Information

  MAUDE report 23006148 ↗
• MalfunctionAug 27, 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. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) CANNULATED REAMER DISTAL/18MM. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079508 ↗
• MalfunctionAug 27, 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. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) CANNULATED REAMER DISTAL/18MM. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079162 ↗
• MalfunctionMay 10, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED ON APRIL 1, 2024 THAT THE REAMERS WERE EXTREMELY DULL AND ARE NO LONGER CUTTING BONE. THE CASE COULD NOT BE COMPLETE WITH THESE ITEMS. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT IS RELATED TO: (B)(4). THIS REPORT IS FOR ONE (1) CANNULATED REAMER DISTAL/18MM THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293909 ↗
• MalfunctionMay 10, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2024 THAT THE REAMERS WERE EXTREMELY DULL AND ARE NO LONGER CUTTING BONE. THE CASE COULD NOT BE COMPLETE WITH THESE ITEMS. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT IS RELATED TO: (B)(4) AND (B)(4). THIS REPORT IS FOR ONE (1) CANNULATED REAMER DISTAL/18MM. THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293804 ↗
• MalfunctionMay 10, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED ON APRIL 1, 2024 THAT THE REAMERS WERE EXTREMELY DULL AND ARE NO LONGER CUTTING BONE. THE CASE COULD NOT BE COMPLETE WITH THESE ITEMS. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT IS RELATED TO: (B)(4) THIS REPORT IS FOR ONE (1) CANNULATED REAMER DISTAL/18MM THIS IS REPORT 9 OF 10 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293803 ↗
• MalfunctionMay 10, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2024 THAT THE REAMERS WERE EXTREMELY DULL AND ARE NO LONGER CUTTING BONE. THE CASE COULD NOT BE COMPLETE WITH THESE ITEMS. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT IS RELATED TO: (B)(4). THIS REPORT IS FOR ONE (1) CANNULATED REAMER DISTAL/18MM THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293795 ↗
• MalfunctionDec 23, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM UNITED (B)(6) 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 10 OF 20 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080945 ↗
• MalfunctionDec 23, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM UNITED KINGDOM 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 9 OF 20 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080772 ↗
• 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 2 OF 20 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080249 ↗