NA 310.37Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982186553), received between Aug 26, 2021 and Aug 26, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY ON AN UNKNOWN DATE IN 2021, A 3.5MM DRILL BIT HAD A LITTLE PIECE BROKE OFF. THIS WAS NOT FROM THE USE. LOOKED LIKE A SMALL FLAKE ON THE DRILL BIT AND IT WAS A TINY SLIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR (1) 3.5MM DRILL BIT/QC/195MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374473 ↗