NA 03.211.124Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982076250), received between Dec 23, 2021 and Aug 29, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (6 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 7 most recent of 7 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 (B)(6) 2024, THE DEVICES WERE DULL. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED REAMER PROXIMAL/24MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20101345 ↗
• 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/24MM. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078476 ↗
• MalfunctionNov 1, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT END THE OF INSTRUMENT IS BROKEN OFF. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) CANNULATED PROXIMAL REAMER Ø24. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049439 ↗
• MalfunctionFeb 22, 2022Failure 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 PROXIMAL REAMER Ø24. THIS IS REPORT 21 OF 21 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578915 ↗
• 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, (4) CANNULATED FOOT REAMERS WERE BLUNT. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) CANNULATED REAMER PROXIMAL/24MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079200 ↗
• 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/24MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079153 ↗
• 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/24MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079136 ↗