NA 7205313Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010251411), received between Sep 6, 2018 and Jan 9, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT BEFORE A SHOULDER ARTHROSCOPY PROCEDURE, IT WAS NOTICED THAT THE INCISOR BLADE 4.5 BLADE'S STERILITY WAS COMPROMISED DUE TO ITS PRIMARY CONTAINER WAS BROKEN (OPEN). THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026695 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN LCA PROCEDURE , THE INCISOR BLADE BROKE. THE BROKEN DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY OF 5 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908639 ↗
• MalfunctionMar 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE 'BLADE' DISASSEMBLED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13743371 ↗
• MalfunctionApr 20, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING SURGERY, INTERNAL TO THE PATIENT, THE MOTOR DRIVE UNIT WAS NOT WORKING AND THE BLADE WAS SHEDDING METAL. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11698512 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED THAT THE INCISORS BLADES WERE DAMAGED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228718 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED THAT THE INCISORS BLADES WERE DAMAGED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228713 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED THAT THE INCISORS BLADES WERE DAMAGED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228710 ↗
• MalfunctionJan 25, 2021Break; Break

  IT WAS REPORTED THAT THE INCISOR BLADE WAS DAMAGED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11221356 ↗
• MalfunctionSep 6, 2018Break; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE SURGEON WAS USING THE BLADE FOR ABOUT 15 MINUTES AND THEN IT STARTED TO SHEARING AND THE INSIDE OF THE SHAVER BLADE SHAFT BECAME REALLY STIFF AND COULDNT BE EASILY PULLED APART TO BE CLEANED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7851796 ↗
• MalfunctionSep 6, 2018Break; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE SURGEON WAS USING THE BLADE FOR ABOUT 15 MINUTES AND THEN IT STARTED TO SHEARING AND THE INSIDE OF THE SHAVER BLADE SHAFT BECAME REALLY STIFF AND COULDN'T BE EASILY PULLED APART TO BE CLEANED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7851795 ↗