NA 395.913Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982200914), received between May 25, 2023 and May 25, 2023 — classified as 2 malfunctions.

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

• MalfunctionMay 25, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS IN QUESTION WERE DISCOVERED TO BE BENT AND DAMAGED. THIS WAS OBSERVED POST-OP WHILE THE ITEMS WERE BEING CLEANED IN STERILE PROCESSING. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM/3.5MM DRILL SLEEVE-LONG. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007184 ↗
• MalfunctionMay 25, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS IN QUESTION WERE DISCOVERED TO BE BENT AND DAMAGED. THIS WAS OBSERVED POST-OP WHILE THE ITEMS WERE BEING CLEANED IN STERILE PROCESSING. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM/3.5MM DRILL SLEEVE-LONG. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007179 ↗