LEVEL ONE 25-449-07-91Recalls & reported problems
KLS-Martin L.P. · TWIST DRILL, J NOTCH, 7 MM STOP · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888118040770), received between Dec 7, 2018 and Dec 16, 2025 — classified as 8 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Fracture3
Patient problems
- Device Embedded In Tissue or Plaque7
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF THE TWIST DRILL REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23816662 ↗InjurySep 12, 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 23037858 ↗InjuryAug 14, 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 22803978 ↗InjuryFeb 13, 2025Break; 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 21375088 ↗InjuryDec 27, 2024Break; Break
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL BROKE DURING USE. A PORTION OF THE TWIST DRILL REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21029621 ↗InjuryAug 10, 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 17497711 ↗InjuryJun 14, 2022Break; Break
IT WAS REPORTED A TWIST DRILL BROKE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 14690950 ↗InjuryDec 7, 2018Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE DURING USE AND THE BROKEN PIECE WAS NOT LOCATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8143597 ↗
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.