LEVEL ONE 01-469-11-07Recalls & reported problems
KLS-Martin L.P. · TWIST DRILL, J NOTCH, MORRISON, 30 MM STOP, 25 MM FLUTE, FOR DRILL GUIDE · Class 1
All models of LEVEL ONE (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888118006769), received between Jun 15, 2018 and Sep 15, 2023 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Use of Device Problem1
Patient problems
- Device Embedded In Tissue or Plaque2
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2023Break; Break
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL BROKE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17760495 ↗InjuryDec 3, 2019Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE AND A PORTION REMAINED IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9400827 ↗InjuryFeb 5, 2019Break; Break
IT WAS REPORTED THE TWIST DRILL BROKE. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8306706 ↗InjuryAug 10, 2018Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED A TWIST DRILL BROKE DURING USE AND WAS REMOVED. IT IS STATED IN IFU 90-274-92-40 "FOR TWIST DRILLS WITH AN OVERALL LENGTH OF GREATER THAN 50 MM, AN APPROPRIATE BURR GUARD OR DRILL GUIDE SHOULD BE USED AT ALL TIMES."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7773727 ↗MalfunctionJun 15, 2018Break; Break
IT WAS REPORTED THE TWIST DRILL BROKE WHILE BEING USED WITHOUT A DRILL GUIDE. ALL PIECES WERE REMOVED. IFU (B)(4) STATES "FOR TWIST DRILLS WITH AN OVERALL LENGTH OF GREATER THAN 50MM, AN APPROPRIATE BURR GUARD OR DRILL GUIDE SHOULD BE USED AT ALL TIMES."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7607354 ↗
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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