NA 03.133.100Recalls & reported problems
Synthes GmbH · 2.0MM DRILL BIT QC 110MM 30MM CALIBRATION · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10886982269591), received between Dec 1, 2025 and Dec 1, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING THE SURGERY, WHEN THE DOCTOR WAS DRILLING THE BONE, IT BECOMES CLEAR THAT THE DRILL BITS WERE NOT SHARP, SO THEY WERE CHANGED OUT FOR OTHERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687539 ↗MalfunctionDec 1, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING THE SURGERY, WHEN THE DOCTOR WAS DRILLING THE BONE, IT BECOMES CLEAR THAT THE DRILL BITS WERE NOT SHARP, SO THEY WERE CHANGED OUT FOR OTHERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687537 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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