2.5mm Drill Bit Calibrated 200mm 110040Recalls & reported problems
Osteocentric Technologies, Inc. · 2.5mm Drill Bit Calibrated 200mm · Class 1
Data updated Oct 18, 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 00816950028373), received between Dec 6, 2023 and Dec 6, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2023Break; Break
IT WAS REPORTED THAT A 2.5MM CALIBRATED DRILL BIT PART # 110040 LOT# CAL008 WAS BEING USED FOR A PELVIS SURGERY AND BROKE OFF IN A PATIENT. THE REMAINING DRILL BIT WAS DISCARDED.
Patient problems: Insufficient Information
MAUDE report 18279476 ↗MalfunctionDec 6, 2023Break; Break
IT WAS REPORTED THAT A 2.5MM CALIBRATED DRILL BIT PART #110040 LOT# DAL008 WAS USED TO DRILL 3 PILOT HOLES IN THE PELVIS. ON THE THIRD HOLE THE DRILL BIT TIP BROKE OFF IN THE PATIENT. THE SURGEON INDICATED HE USED A NEW DRILL AND PROPER SCREW FIXATION PROCEEDED. THE SURGEON INDICATED THAT HE WAS USING THE DRILL OUTSIDE OF NORMAL USE. THE REMAINING PORTION OF THE DRILL BIT WAS DISCARDED AND THEREFORE COULD NOT BE RETURNED FOR INVESTIGATION.
Patient problems: Insufficient Information
MAUDE report 18279295 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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