FMS 283209Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705027187), received between May 14, 2018 and Mar 18, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Break; Break

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY SURGERY, IT WAS OBSERVED THAT TWO 2.7MM MINI FULL RAD PLUS DEVICES SNAPPED IN HALF DURING USE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21629622 ↗
• MalfunctionMar 18, 2025Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY SURGERY, IT WAS OBSERVED THAT TWO 2.7MM MINI FULL RAD PLUS DEVICES SNAPPED IN HALF DURING USE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21629586 ↗
• MalfunctionSep 10, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN USING THE MINI FULL RADIUS BLADE PLUS IN A WRIST ARTHROSCOPY CASE BITS OF METAL SWARF WERE NOTICED IN THE JOINT. THIS WAS FLUSHED OUT BUT CAUSED A DELAY TO SURGERY OF AROUND 10 MINUTES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8982336 ↗
• MalfunctionMay 14, 2018Metal Shedding Debris; Metal Shedding Debris

  IT WAS REPORTED BY THE AFFILIATE THAT SILVER METALLIC DEBRIS WAS SEEN COMING FROM THE BLADE DURING USE. THE BLADE WAS SWAPPED 3 TIMES AND ALL 3 BLADES SHOWED THE SAME ISSUE. THESE ITEMS CANNOT BE DECONTAMINATED BY THE ACCOUNT THEREFORE HAVE HAD TO BE DISPOSED OF. I WILL BE COLLECTING THE PACKAGING FROM THE PRODUCTS TOMORROW ((B)(6)) IN ORDER TO GET THE LOT CODES AND ALSO TO DISCUSS FURTHER WITH THE SURGEON ABOUT WHAT HAPPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7511963 ↗
• MalfunctionMay 14, 2018Metal Shedding Debris; Metal Shedding Debris

  IT WAS REPORTED BY THE AFFILIATE THAT SILVER METALLIC DEBRIS WAS SEEN COMING FROM THE BLADE DURING USE. THE BLADE WAS SWAPPED 3 TIMES AND ALL 3 BLADES SHOWED THE SAME ISSUE. THESE ITEMS CANNOT BE DECONTAMINATED BY THE ACCOUNT THEREFORE HAVE HAD TO BE DISPOSED OF. I WILL BE COLLECTING THE PACKAGING FROM THE PRODUCTS TOMORROW ((B)(6)) IN ORDER TO GET THE LOT CODES AND ALSO TO DISCUSS FURTHER WITH THE SURGEON ABOUT WHAT HAPPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7511918 ↗
• MalfunctionMay 14, 2018Metal Shedding Debris; Metal Shedding Debris

  IT WAS REPORTED BY THE AFFILIATE THAT SILVER METALLIC DEBRIS WAS SEEN COMING FROM THE BLADE DURING USE. THE BLADE WAS SWAPPED 3 TIMES AND ALL 3 BLADES SHOWED THE SAME ISSUE. THESE ITEMS CANNOT BE DECONTAMINATED BY THE ACCOUNT THEREFORE HAVE HAD TO BE DISPOSED OF. I WILL BE COLLECTING THE PACKAGING FROM THE PRODUCTS TOMORROW ((B)(6)) IN ORDER TO GET THE LOT CODES AND ALSO TO DISCUSS FURTHER WITH THE SURGEON ABOUT WHAT HAPPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7511902 ↗