NA 7210909Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010582737), received between Feb 14, 2019 and May 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Flaked” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 16, 2025Break; Material Deformation; Material Twisted/Bent; Scratched Material; Insufficient Device Problem Information; Physical Resistance/Sticking; Break; Material Deformation; Material Twisted/Bent; Scratched Material; Insufficient Device Problem Information; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A MENISCECTOMY, THE DISPOSABLE BLADE STOPPED WORKING, AND WHEN IT WAS REMOVED FROM THE HANDPIECE, THE TIP WAS GETTING STUCK WHEN TURNING. THE PROCEDURE WAS COMPLETED WITHOUT ANY SURGICAL DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039725 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A CUFF PROCEDURE, THE SURGEON BROKE THE FULL RADIOS BLADE AND CLAIMED IT WAS OF POOR QUALITY. THE PIECES WERE REMOVED. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. NO DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649010 ↗
• MalfunctionSep 30, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, METAL DEBRIS WERE DEPOSITED IN THE KNEE DURING USE OF THE KNIFE BLADE 5.5 FULL RADIUS ELITE DISPOSABLE. THE DEBRIS WAS RETRIEVED BY SUCTION. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339093 ↗
• MalfunctionAug 5, 2024Flaked; Material Twisted/Bent; Mechanical Jam; Flaked; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY, THE USE OF THE BLADE 5.5 FULL RADIUS LOCKED THE HANDPIECE AND WHITE POWDER CAME OUT WHEN THE BLADE WAS FORCE TO BE USED. IT BROKE SEVERAL TIMES DURING THE SURGERY. THE PROCEDURE WAS A COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906928 ↗
• MalfunctionDec 18, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE 5.5 MM BLADE ELITE HAD A STRONG METAL ABRASION. THE ROOT CAUSE OF THE FAILURE IS UNCLEAR. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18348770 ↗
• MalfunctionFeb 14, 2019Mechanical Problem

  IT WAS REPORTED THAT THE SHAVER WAS INSERTED INTO THE PATIENT AND IT DOES NOT MOVE. WHEN FINALLY MOVES, THE SHAVER TEETH WERE PUSHED OUTSIDE. . THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342077 ↗