NA 359.206Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982197078), received between Jun 28, 2023 and Jul 17, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 17, 2025Break; Material Deformation; Scratched Material; Break; Material Deformation; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2025 THE DEVICES WERE FOUND TO HAVE MANY DENTS, CHIPS, AND SCORING. THERE WAS NO OPERATION AND PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532845 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE BEVELED TAMP INSTRUMENT WAS CHIPPED AND WILL NEED REPLACEMENT IN STERILE PROCESSING. NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149778 ↗
• MalfunctionJun 28, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE TAMP/BEVELED. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216708 ↗