NA 513.13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982238627), received between Apr 5, 2024 and Apr 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (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.

• MalfunctionApr 5, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED INTRAOPERATIVELY ON MARCH 16, 2024 TWO (2) 2.0 DRILL BITS WERE COMPLETELY DULL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT IS LISTED AS STABLE. THIS REPORT IS FOR ONE 2.0MM DRILL BIT/MINI QC/52MM (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050903 ↗