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NA 03.019.016Recalls & reported problems

Synthes GmbH · 3.8MM THREE-FLUTED DRILL BIT QC/CALIBRATED/270MM · 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 10886982069535), received between Jun 11, 2019 and Dec 15, 2020 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device-Device Incompatibility1
  • Failure to Cut1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionDec 15, 2020Failure to Cut; Failure to Cut

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INVENTORY, AND RESTOCKING OF A LOANER SET WITH NEW DRILL BITS, IT WAS DISCOVERED THAT THE TIP OF A THREE FLUTED DRILL BIT WAS SQUARED OFF AND BLUNT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 3.8MM THREE-FLUTED DRILL BIT QC/CALIBRATED/270MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11006564 ↗
  • MalfunctionJun 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

    CONCOMITANT DEVICE: MULITLOC HUMERAL NAIL (PART/LOT UNKNOWN, QUANTITY 1).

    Patient problems: No Patient Involvement

    MAUDE report 8689127 ↗

Other BIT, SURGICAL devices

All BIT, SURGICAL devices →

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