LEVEL ONE 25-449-05-91Recalls & reported problems
KLS-Martin L.P. · TWIST DRILL, J NOTCH, 5 MM STOP · Class 1
All models of LEVEL ONE (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118040763), received between Feb 1, 2019 and Apr 9, 2019 — classified as 3 injuries.
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 16, 2026.
Most reported problems
Device problems
- Break2
- Temperature Problem1
Patient problems
- No Consequences Or Impact To Patient2
- Burn(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2019Temperature Problem; Temperature Problem
InjuryFeb 8, 2019Break; Break
IT WAS REPORTED THAT A TWIST DRILL DIAMETER INDICATOR RING BROKE OFF DURING USE AND IT WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8319987 ↗InjuryFeb 1, 2019Break; Break
IT WAS REPORTED THAT A TWIST DRILL DIAMETER INDICATOR RING BROKE OFF DURING USE AND IT WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8298212 ↗
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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