LEVEL ONE 25-452-05-91Recalls & reported problems
KLS-Martin L.P. · TWIST DRILL, J NOTCH, 5 MM STOP · Class 1
All models of LEVEL ONE (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888118040978), received between Feb 17, 2017 and Jun 24, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Fracture2
- Difficult to Remove1
Patient problems
- Device Embedded In Tissue or Plaque9
- Impaired Healing1
Recent adverse event reports
The 10 most recent of 10 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 25610331 ↗InjuryDec 10, 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 23769293 ↗InjuryMay 8, 2024Break; Break
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL BROKE DURING USE. A PORTION OF IT REMAINED IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19273699 ↗InjuryDec 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 18393081 ↗InjuryApr 14, 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 16742114 ↗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 15978921 ↗InjuryApr 25, 2022Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE AND PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 14197450 ↗InjuryJan 14, 2022Break; 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 13258534 ↗InjuryFeb 1, 2019Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE. ALL PIECES WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 8298205 ↗InjuryFeb 17, 2017Break; Difficult to Remove
DOCTOR WAS PRE DRILLING HOLES IN THE PEEK IMPLANT WHILE IT WAS OUTSIDE THE PATIENTS HEAD. SURGEON TOOK HIS FINGER OFF OF THE DRILL BEFORE HE WAS DONE DRILLING AND THE TWIST DRILL GOT STUCK IN THE PEEK IMPLANT. WHEN THEY WERE TRYING TO REMOVE IT THEY ROCKED THE TWIST DRILL BACK AND FORTH AND IT BROKE A LITTLE PIECE OF THE TWIST DRILL OFF INSIDE THE PEEK IMPLANT. IT WASN'T SHARP AND WASN'T ALL THE WAY THROUGH TO THE OTHER SIDE. DOCTOR DECIDED TO LEAVE IT IMPLANTED IN THE PEEK AND THEN PROCEEDED TO FINISH THE CASE. THE REST OF THE TWIST DRILL WAS DISCARDED IN THE SHARPS CONTAINER.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6339022 ↗
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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