NA 7205314Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010251428), received between Feb 21, 2018 and Apr 29, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Flaked” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE PACKAGING OF THE INCISOR BLADE WAS BROKEN, AFFECTING THE STERILITY OF THE BLADE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930658 ↗
• InjuryAug 30, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN OPERATING THE SHAVER, METAL PARTICLES FELL FROM THE INCISOR BLADE AND REMAINED IN THE JOINT, THERE WAS NO CONTACT WITH BONE, LENS OR ANYTHING THAT WOULD ALLOW THE PARTICLES TO SPREAD, THE BLADE WAS ONLY IN CONTACT WITH SOFT TISSUE. THE MAJORITY OF THE PARTICLES WERE REMOVED USING ANOTHER BACKUP BLADE AND BY WASHING THE JOINT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20107257 ↗
• MalfunctionMay 2, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY METAL FILINGS WERE SEEN WHEN USING THE INCISOR 5.5MM EP-1 DSPL BLADE. NO UNDUE FORCE WAS APPLIED ON THE SHAVER BLADE. A SECOND BLADE WAS OPENED AND USED TO REMOVE METAL DEBRIS. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16855828 ↗
• InjuryDec 16, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, METAL PARTICLES WERE PRODUCED WHEN TWO(2) INCISOR BLADES WERE USED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE AND IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENTS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995797 ↗
• InjuryJan 20, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE SHAVER PRODUCED AN EXTENSIVE AMOUNT OF SMALL METAL SHAVINGS INTO THE PATIENT. PROCEDURE WAS COMPLETED WITH THE SAME INCISOR 5.5MM BLADE. NO DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. MI IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11200773 ↗
• MalfunctionApr 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN IT WAS USING THE 5,5 MM BLADE, SOME SILVER PARTICLES WERE OBSERVED IN THE TISSUE, THE DOCTOR REALIZED THAT THEY WERE FROM THE BLADE WHEN IT WAS USED WITH THE SHAVER HANDPIECE, THE PARTICLES WERE REMOVED FROM THE TISSUE BY IRRIGATION - SUCTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7405316 ↗
• MalfunctionMar 14, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT WHILE THE JOINT WAS BEING CLEANED IT WAS NOTICED THAT THE BLADE WAS RELEASING METAL PARTICLES, AND THESE SPREAD THROUGHOUT THE JOINT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339775 ↗
• MalfunctionFeb 21, 2018Metal Shedding Debris

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN IT WAS USING THE 5,5 MM BLADE, SOME SILVER PARTICLES WERE OBSERVED IN THE TISSUE, THE DOCTOR REALIZED THAT THEY ARE FROM THE BLADE WHEN IT WAS USED WITH THE SHAVER HANDPIECE, THE PARTICLES WERE REMOVED FROM THE TISSUE BY IRRIGATION - SUCTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287437 ↗