LEVEL ONE 25-454-07-91Recalls & reported problems
KLS-Martin L.P. · TWIST DRILL, J NOTCH, 7 MM STOP · Class 1
All models of LEVEL ONE (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888118041067), received between Mar 12, 2018 and Jun 13, 2025 — classified as 7 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Fracture1
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque5
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL BROKE DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22205090 ↗InjuryFeb 13, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL BROKE DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21375086 ↗InjuryOct 15, 2020Break; Break
IT WAS REPORTED A TWIST DRILL BROKE DURING USE AND IT IS SUSPECTED THAT A PORTION REMAINED IMPLANTED. THE REPORTED RPMS EXCEEDED THE MAXIMUM VALUE FOUND IN THE IFU. PER IFU 91-600-02-00 FOR THE TWIST DRILL "OPERATE THE TWIST DRILLS WITH NO MORE THAN THE MAXIMUM RECOMMENDED HANDPIECE SPEED SETTING OF 2,500 RPM."
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10683426 ↗InjuryMay 11, 2020Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE AND A PORTION REMAINED IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10042900 ↗InjuryNov 5, 2018Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE DURING USE. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8038591 ↗InjurySep 7, 2018Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE DURING USE. THE TWIST DRILL WAS REMOVED FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7856078 ↗InjuryMar 12, 2018Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE AND THE TIP REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7330122 ↗
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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