NA 03.211.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982076144), received between Dec 23, 2021 and Sep 9, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (9 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 9 most recent of 9 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 23006136 ↗
• MalfunctionMay 15, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED DURING SURGERY FOR A FOOT PROCEDURE, ON (B)(6) 2024, THAT THE REAMERS WERE EXTREMELY DULL AND WERE NO LONGER CUTTING BONE. CANNOT COMPLETE CASE WITH THESE ITEMS. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE CANNULATED REAMER DISTAL/22MM FOR (B)(4). (B)(4). IS LINKED TO (B)(4) AND (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325781 ↗
• MalfunctionMay 15, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED DURING SURGERY FOR A FOOT PROCEDURE, ON (B)(6) 2024, THAT THE REAMERS WERE EXTREMELY DULL AND WERE NO LONGER CUTTING BONE. CANNOT COMPLETE CASE WITH THESE ITEMS. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE CANNULATED REAMER DISTAL/22MM FOR (B)(4). (B)(4) TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325778 ↗
• MalfunctionMay 15, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED DURING SURGERY FOR A FOOT PROCEDURE, ON (B)(6) 2024, THAT THE REAMERS WERE EXTREMELY DULL AND WERE NO LONGER CUTTING BONE. CANNOT COMPLETE CASE WITH THESE ITEMS. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE CANNULATED REAMER DISTAL/22MM FOR (B)(4). (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325777 ↗
• 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/22MM THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293790 ↗
• MalfunctionMar 16, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE ROUTINE USE TWO(2) OF THE CANNULATED PROXIMAL REAMER WAS FOUND TO BE BLUNT. THE INSTRUMENTS WERE OFTEN USED MULTIPLE TIMES A WEEK AND HAVE BEEN IN CIRCULATED FOR 18-24 MONTHS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANNULATED REAMER DISTAL/22MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16557097 ↗
• 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 8 OF 20 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080718 ↗
• 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 7 OF 20 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080606 ↗
• 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 1 OF 20 FOR (B)(4) ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078229 ↗