NA 310.229Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982186256), received between Dec 22, 2021 and May 1, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Failure to Cut

  IT WAS REPORTED THE DRILL BITS WOULD NOT CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056663 ↗
• MalfunctionMay 30, 2024Break; Break

  IT WAS REPORTED DURING INSPECTION OF THE LOAN KIT, IT WAS NOTED THE TIP OF THE INSTRUMENT HAD SNAPPED OFF. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT REPORTED. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19424706 ↗
• MalfunctionDec 22, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A 2.0 INTRAOPERATIVE DRILL BIT SPLIT DURING A PROCEDURE ON (B)(6) 2021. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR ONE (1) 2.9MM DRILL BIT/QC/150MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063832 ↗