FMS 283403Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705025930), received between Apr 22, 2024 and Feb 2, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionFeb 2, 2026Break; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE CRVD FULL RADIUS BLADE 4.2 MM DEVICE DID NOT FUNCTION AS EXPECTED AND WAS HEAVY-HANDED. AT ONE POINT THE TIP OF THE INNER SHEATH WAS BROKEN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235791 ↗
• MalfunctionDec 8, 2025Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE CRVD FULL RADIUS BLD 4.2MM DEVICE BROKE IN HALF DURING USE, WHICH GENERATED METAL DEBRIS ON THE KNEE. THE DEVICE WAS CHANGED TO ANOTHER DEVICE AND THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THE KNEE WAS CLEANED AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740415 ↗
• MalfunctionDec 8, 2025Break; Material Deformation; Break; Material Deformation

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE CRVD FULL RADIUS BLD 4.2MM DEVICE BROKE IN HALF DURING USE, WHICH GENERATED METAL DEBRIS ON THE KNEE. THE DEVICE WAS CHANGED TO ANOTHER DEVICE AND THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THE KNEE WAS CLEANED AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740100 ↗
• MalfunctionAug 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CRVD FULL RADIUS BLD 4.2MM 5PK DEVICE DID NOT LOCK ONTO SHAVER HANDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784659 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE THE CRVD FULL RADIUS BLD 4.2MM DEVICE HAD A BROKEN SHAVER BLADE. FRAGMENTS WERE GENERATED BUT WERE EASILY REMOVED WITHOUT INTERVENTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19156874 ↗