NA 03.008.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982066862), received between Oct 27, 2021 and Mar 13, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 13, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRILL BITS DID NOT CUT WELL. THERE WAS A LOT OF DIFFICULTY TO PIERCE THE BONE.

  Patient problems: Insufficient Information

  MAUDE report 21594167 ↗
• MalfunctionOct 27, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, TWO (2) DRILL BITS WERE FOUND TO BE DULL AND UNABLE TO DRILL IN THE BONE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø5 CALIBR L356 3FLUTE F/03.010. THIS IS REPORT 1 OF 2 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703442 ↗