NA 309.150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982185631), received between Aug 31, 2023 and Aug 31, 2023 — 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.

• MalfunctionAug 31, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT UPON CLEANING, STAFF NOTICED THAT THE INSIDE PIECE OF THE HOLLOW REAMER WAS BROKEN. IT COULD NO LONGER CAPTURE THE SCREW. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE HOLLOW REAMER-COMPLETE FOR 1.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663201 ↗