NA 03.010.034Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982067067), received between Apr 6, 2022 and Apr 6, 2022 — 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.

• MalfunctionApr 6, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE FOUR (4) 13MM DRILL BITS FROM THE RAFN SETS ARE DULL AND REQUIRE SHARPENING. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 13.0MM FLEXIBLE CANNULATED DRILL BIT LARGE QC/465MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14027256 ↗
• MalfunctionApr 6, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE FOUR (4) 13MM DRILL BITS FROM THE RAFN SETS ARE DULL AND REQUIRE SHARPENING. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 13.0MM FLEXIBLE CANNULATED DRILL BIT LARGE QC/465MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14027017 ↗