NA 7205687Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010373229), received between Jan 29, 2018 and May 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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 27, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT AN UNKNOWN QTY OF INCISOR BLADES BOXES WERE GETTING WEDGED IN THE SLEEVE AND BREAKING WHEN ATTEMPTING TO FIX IT. THERE WERE METAL SHARDS WHEN ATTEMPTING TO FIX IT. THE EXACT MOMENT AT WHICH THE ISSUE WAS NOTICED IS UNKNOWN. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311246 ↗
• MalfunctionMay 22, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT FIVE (5) INCISOR BLADES BOXES WERE GETTING WEDGED IN THE SLEEVE AND BREAKING WHEN ATTEMPTING TO FIX IT. THERE WERE METAL SHARDS WHEN ATTEMPTING TO FIX IT. THE EXACT MOMENT AT WHICH THE ISSUE WAS NOTICED IS UNKNOWN. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256540 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ORBIT INCISOR BLADE KNIFE BROKE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419326 ↗
• MalfunctionFeb 19, 2020Flaked; Flaked

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE 4.5 ORBIT INCISOR PLUS WAS DEFECTIVE AND IT WAS SHEDDING METAL INSIDE THE JOINT. THE SURGEON STATED THE METAL IN THE JOINT WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING ANOTHER SHAVER BLADE OF THE SAME TYPE (ORBIT) 4.5 MM. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9729359 ↗
• MalfunctionJan 29, 2018Break

  IT WAS REPORTED THAT THE TIP OF THE BLADE BROKE DURING USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7226414 ↗