NA 04.033.240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982271426), received between May 7, 2022 and May 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionMay 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A SURGICAL PROCEDURE, WHILE DRILLING THE SURGEON MADE CONTACT WITH NAIL AND THE DRILL BIT PASSED THROUGH THE NAIL. THERE WAS NO ISSUE PLACING THE SCREW. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE HAD COMPLETED SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE 4.2 3-FLTD DRILL BIT QC/330/100 CALIB. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14321326 ↗