NA 03.617.912Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034717210), received between Sep 26, 2018 and Sep 26, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 26, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SALES REP ATTENDED A CASE WHERE THE 2.0MM X12MM DRILL BIT SNAPPED. THE AWL ALSO BENT SLIGHTLY. THE SURGEON SUGGESTED THAT IT COULD OF BEEN DUE TO THEM PUSHING AGAINST THE INSITU VERTEBRAL BODY DISTRACTION PIN. THERE WAS NO HARM TO THE PATIENT OR THEATRE STAFF. THE CASE PROCEEDED WITHOUT FURTHER INCIDENT. THIS REPORT IS FOR 1 2.0MM X12MM DRILL BIT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7911391 ↗