Formula 0375555000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327061864), received between Feb 22, 2023 and Dec 18, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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.

• MalfunctionDec 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. PLEASE NOTE THAT WHILE THIS RESULTED IN REPORTED CARTILAGE DAMAGE, THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AND NO SURGICAL DELAY DUE TO THIS.

  Patient problems: Cartilage damage

  MAUDE report 20972873 ↗
• MalfunctionNov 20, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING THE USE OF THE BUR, A SIGNIFICANT AND UNUSUAL HEATING OCCURRED AT THE ROTATION OF THE 2 PARTS, WHICH RESULTED IN A MILD BURN WITH NO SEVERITY OR IMPACT ON THE PATIENT THAT SURGEON WAS ABLE TO MANAGE. NO REPORTED ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Burn(s)

  MAUDE report 20740817 ↗
• MalfunctionFeb 27, 2024Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793839 ↗
• MalfunctionSep 22, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17801276 ↗
• MalfunctionFeb 22, 2023Nonstandard Device; Packaging Problem; Nonstandard Device; Packaging Problem

  IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420440 ↗