NA 03.211.122Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982076243), received between Nov 19, 2021 and Sep 9, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (15 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 15 most recent of 15 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 23006138 ↗
• 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/22MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20101257 ↗
• 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 PROXIMAL/22MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078568 ↗
• MalfunctionMay 14, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED ON APRIL 1 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 PROXIMAL REAMER Ø22.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19316182 ↗
• MalfunctionMay 14, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED ON APRIL 1 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 PROXIMAL REAMER Ø22.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19316178 ↗
• MalfunctionMay 14, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED ON APRIL 1 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 PROXIMAL REAMER Ø22.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19316177 ↗
• 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 PROXIMAL/22MM THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293787 ↗
• MalfunctionAug 11, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BLUNT THROUGH GENERAL WEAR AND TEAR. THIS REPORT INVOLVES ONE (1) CANNULATED REAMER PROXIMAL/22MM. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17511337 ↗
• MalfunctionAug 11, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BLUNT THROUGH GENERAL WEAR AND TEAR. THIS REPORT INVOLVES ONE (1) CANNULATED REAMER PROXIMAL/22MM. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509545 ↗
• 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 PROXIMAL/22MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16557223 ↗
• 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 20 OF 20 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13081770 ↗
• 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 19 OF 20 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13081741 ↗
• MalfunctionDec 23, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, FOUR (4) CANNULATED FOOT REAMERS WERE BLUNT. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CANNULATED REAMER PROXIMAL/22MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079199 ↗
• MalfunctionNov 19, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) CANNULATED DISTAL REAMERS AND TWO (2) CANNULATED PROXIMAL REAMERS WERE FOUND TO BE BLUNT. THE COMPLAINT COMES FROM A SURGEON. THERE HAS NOT BEEN ANY DANGER TO PATIENT SAFETY AND THERE IS NO SPECIFIC CASE OR SURGERY LINKED TO THE COMPLAINT. THIS REPORT IS FOR ONE (1) CANNULATED REAMER PROXIMAL/22MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847081 ↗
• MalfunctionNov 19, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) CANNULATED DISTAL REAMERS AND TWO (2) CANNULATED PROXIMAL REAMERS WERE FOUND TO BE BLUNT. THE COMPLAINT COMES FROM A SURGEON. THERE HAS NOT BEEN ANY DANGER TO PATIENT SAFETY AND THERE IS NO SPECIFIC CASE OR SURGERY LINKED TO THE COMPLAINT. THIS REPORT IS FOR ONE (1) CANNULATED REAMER PROXIMAL/22MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847059 ↗