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NA 03.161.055Recalls & reported problems

Synthes GmbH · 3.8MM DRILL BIT WITH 20MM STOP QC · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034711713), received between Mar 6, 2017 and Oct 11, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Device problems

  • Break2

Patient problems

  • No Patient Involvement2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 11, 2019Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2019, THE DRILL BIT WAS DISCOVERED BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.8MM DRILL BIT WITH 20MM STOP QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 9180936 ↗
  • MalfunctionMar 6, 2017Break; Break

    IT WAS CONFIRMED THAT THE INSTRUMENTS (DRILL BIT AND HANDLE FOR QUICK COUPLING) WERE NOT USED IN A PROCEDURE. IT IS UNKNOWN WHEN THE DEVICES BECAME STUCK TOGETHER.

    Patient problems: No Patient Involvement

    MAUDE report 6380911 ↗

Other BIT, DRILL devices

All BIT, DRILL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.