FMS 283309Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705027224), received between Apr 19, 2021 and May 23, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ARTHROSCOPIC PROCEDURE OF THE ANKLE ON (B)(6) 2023, IT WAS OBSERVED THAT EXCESSIVE METAL FILINGS WERE GENERATED FROM THE USE OF RADIUS BLADE PLUS DEVICE. REMOVED ALL THE FRAGMENTS. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984694 ↗
• MalfunctionMay 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS OBSERVED THAT THE 3.5MM FULL RADIUS PLUS 5PK HAD NO SUCTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807844 ↗
• MalfunctionMay 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS OBSERVED THAT THE 3.5MM FULL RADIUS PLUS 5PK HAD NO SUCTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807843 ↗
• MalfunctionMay 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS OBSERVED THAT THE 3.5MM FULL RADIUS PLUS 5PK HAD NO SUCTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807842 ↗
• MalfunctionApr 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN SINGAPORE THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SHAVER ATTACHMENT DEVICE WAS BLOCKED AFTER ONE USAGE THAT IT WAS NOT ABLE TO FLUSH THE DEBRIS OUT THUS UNABLE TO CONTINUE USING TO SHAVE SOFT TISSUE AFTER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688401 ↗