LEVEL ONE 25-452-00-91Recalls & reported problems
KLS-Martin L.P. · TWIST DRILL, J NOTCH, 17 MM STOP · Class 1
Quick summary
This KLS-Martin twist drill is a surgical bit used to drill a starter hole with a J notch. The 30 reports mostly describe the drill tip snapping off during surgery, sometimes leaving a broken piece behind in the bone or tissue. No deaths were reported; all 30 reports describe injuries. There are no recalls naming 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
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888118040954), received between May 16, 2018 and Aug 13, 2026 — classified as 30 injuries.
The most frequently reported specific device problem is “Break” (21 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break21
- Fracture9
- Use of Device Problem1
Patient problems
- Device Embedded In Tissue or Plaque24
- No Consequences Or Impact To Patient5
- Impaired Healing1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Fracture
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50241945 ↗InjuryJun 5, 2026Fracture
IT WAS REPORTED THAT 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 25412669 ↗InjuryApr 30, 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 25046693 ↗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 24306763 ↗InjuryDec 9, 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 23760864 ↗InjuryNov 5, 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 23477570 ↗InjuryJul 30, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY THAT TWIST DRILLS FRACTURED DURING USE. A PORTION OF THEM REMAIN IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22668280 ↗InjuryApr 24, 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 21904081 ↗InjuryMar 5, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DUE TO IT WAS NOT PLACED PERPENDICULAR TO THE BONE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21529165 ↗InjuryNov 15, 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 20698810 ↗InjuryAug 22, 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 20034211 ↗InjuryJun 5, 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 19467629 ↗InjuryDec 13, 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 18317865 ↗InjuryOct 26, 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 18015921 ↗InjuryFeb 14, 2023Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 16375261 ↗InjuryDec 14, 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 15978815 ↗InjuryMar 4, 2022Break; Break
IT WAS REPORTED A TWIST DRILL BROKE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13672060 ↗InjuryJul 21, 2021Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE, AND A PORTION OF IT REMAINS IMPLANTED. THE REPORTED RPMS EXCEEDED THE MAXIMUM RECOMMENDED SPEED FOUND IN THE IFU.
Patient problems: Impaired Healing
MAUDE report 12205941 ↗InjuryJul 2, 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 12112000 ↗InjuryMay 21, 2021Break; Break
IT WAS REPORTED A TWIST DRILL BROKE AND A PORTION REMAINED IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11866983 ↗InjuryMay 13, 2021Break; Break
IT WAS REPORTED A TWIST DRILL BROKE AND A PORTION REMAINS IMPLANTED. PER IFU 91-600-02-00 FOR THE TWIST DRILL "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 2500 RPM."
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11819367 ↗InjuryMar 26, 2020Break; Break
IT WAS REPORTED A TWIST DRILL BROKE AND A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9885078 ↗InjuryFeb 26, 2020Break; Break
IT WAS REPORTED A TWIST DRILL BROKE AND A PORTION REMAINED IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9757021 ↗InjuryFeb 1, 2019Break; Break
IT WAS REPORTED THE TWIST DRILL BROKE. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8298210 ↗InjuryJan 11, 2019Break; Break
IT WAS REPORTED A TWIST DRILL BROKE. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8240545 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.