NA 7205318Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010251466), received between May 15, 2020 and Jan 5, 2026 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Flaked

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH MENISCECTOMY, METAL SHAVINGS FROM A RAZORCUT BLADE BROKE OFF. THE SURGEON WAS ABLE TO SUCTION OUT ALL OF THE SHAVINGS TO THE BEST OF HIS ABILITY. THE PROCEDURE WAS RESUMED, AFTER A FIVE-MINUTE DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960793 ↗
• InjuryJan 10, 2022Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY SURGERY, THE RAZORCUT BLADE TOP WAS BEING SHAVED OFF, IT CREATED METAL FLAKE IMMEDIATELY AFTER USE. IT IS UNKNOWN IF THE PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13202086 ↗
• InjuryMay 15, 2020Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, A BLADE WAS OPENED AND ONCE IT WAS MOUNTED ON THE SHAVER IT DID NOT TURN, THE INTERNAL ROTARY OF THE BLADE STRUGGLED TO TURN INSIDE THE EXTERNAL METAL CANNULA. THEN, TRYING TO TURN IT BY HAND WAS VERY DIFFICULT AND DID NOT HAVE THE USUAL SMOOTH ROTATION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY AND NO OTHER COMPLICATIONS WERE REPORTED. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD SIGNS OF SHEDDING/FLAKING WHICH MAKES IT A REPORTABLE EVENT. 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 10063863 ↗