LEVEL ONE 25-449-16-91Recalls & reported problems
KLS-Martin L.P. · TWIST DRILL, J NOTCH, 21 MM STOP · Class 1
All models of LEVEL ONE (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This KLS-Martin twist drill is a surgical drilling bit used in bone procedures. Most of the 35 reports describe the drill tip breaking or fracturing during surgery, sometimes leaving a fragment behind in the patient, with 34 injuries and no deaths reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00888118040817), received between Jan 19, 2018 and Jun 24, 2026 — classified as 34 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (29 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
- Break29
- Fracture6
- Use of Device Problem1
Patient problems
- Device Embedded In Tissue or Plaque28
- No Consequences Or Impact To Patient7
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Fracture
IT WAS REPORTED DURING INITIAL SURGERY THAT A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25610336 ↗InjuryFeb 10, 2026Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24306760 ↗InjuryOct 22, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23359953 ↗InjuryAug 29, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22926503 ↗InjuryMar 27, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21712130 ↗InjuryJul 25, 2024Break; Break
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 19825786 ↗InjuryFeb 14, 2024Break; Break
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 18705994 ↗InjuryJan 17, 2024Break; Break
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 18530423 ↗InjurySep 15, 2023Break; Break
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 17760504 ↗InjuryJul 21, 2023Break; Break
IT WAS REPORTED DURING AN INITIAL SURGERY A TWIST DRILL BROKE DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17375073 ↗InjuryJun 30, 2023Break; Break
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 17240081 ↗InjuryJun 22, 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 17182182 ↗InjuryJun 7, 2023Break; Break
IT WAS REPORTED A TWIST DRILL BROKE DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17083304 ↗InjuryJan 27, 2023Break; Break
IT WAS REPORTED A TWIST DRILL BROKE DURING USE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 16253282 ↗InjurySep 23, 2022Break; Break
IT WAS REPORTED A TWIST DRILL BROKE DURING USE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 15473161 ↗InjuryJul 1, 2022Break; Break
IT WAS REPORTED A TWIST DRILL BROKE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 14892538 ↗InjuryMay 19, 2022Break; Break
IT WAS REPORTED THAT DURING AN INITIAL SURGERY A TWIST DRILL BROKE. AND A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 14434738 ↗InjuryDec 29, 2021Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE, AND A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13109895 ↗InjuryNov 17, 2021Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE, AND A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12829845 ↗InjuryNov 3, 2021Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE, AND A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12748928 ↗InjuryAug 11, 2020Break; Break
IT WAS REPORTED A TWIST DRILL BROKE AND A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10393645 ↗InjuryMay 28, 2020Break; Break
IT WAS REPORTED A TWIST DRILL BROKE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10095826 ↗InjuryApr 3, 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 9920759 ↗InjuryDec 3, 2019Break; Break
IT WAS REPORTED THE TWIST DRILL BROKE DURING USE AND A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9403682 ↗InjuryApr 16, 2019Break; Break
IT WAS REPORTED A TWIST DRILL BROKE AND A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8518275 ↗
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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