LEVEL ONE 25-469-11-07Recalls & reported problems
KLS-Martin L.P. · TWIST DRILL, J NOTCH, 30 MM STOP, 25 MM FLUTE · Class 1
All models of LEVEL ONE (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This KLS-Martin twist drill is a surgical bone-cutting bit used during orthopedic procedures. The 33 reports mostly describe the drill tip breaking off during use, sometimes leaving a fragment in the patient, along with a few handling complaints. All 33 reports involve injuries, with no deaths reported. There are no recalls naming this device, and no reports came in during the past 12 months compared with 2 in the prior12 months.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00888118041272), received between Aug 16, 2017 and Jun 26, 2025 — classified as 33 injuries.
The most frequently reported specific device problem is “Break” (30 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
- Break30
- Use of Device Problem4
- Fracture3
- Device Handling Problem1
Patient problems
- Device Embedded In Tissue or Plaque19
- No Consequences Or Impact To Patient12
- Laceration(s)1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 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 22337778 ↗InjuryMay 2, 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 21954332 ↗InjuryOct 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 20532062 ↗InjuryAug 6, 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 19916968 ↗InjuryMar 20, 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 18946008 ↗InjuryAug 25, 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 17624362 ↗InjuryJul 21, 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 17374721 ↗InjuryJul 7, 2023Break; 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 17283054 ↗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 17242087 ↗InjuryMar 18, 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 13804745 ↗InjurySep 3, 2020Break; Break
IT WAS REPORTED A TWIST DRILL BROKE DURING USE AND A PORTION REMAINS IMPLANTED. 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 10490906 ↗InjuryJan 21, 2020Break; Break
IT WAS REPORTED THAT A 115MM TWIST DRILL BROKE DURING USE AND A BURR GUARD OR DRILL GUIDE WAS NOT USED. A PORTION OF THE TWIST DRILL REMAINED IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9610265 ↗InjuryAug 13, 2019Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE AND A PORTION REMAINED IMPLANTED. PER IFU 90-274-92-40 FOR THE TWIST DRILL "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 5000 RPM."
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8888079 ↗InjuryApr 9, 2019Break; Device Handling Problem; Break; Device Handling Problem
IT WAS REPORTED TWIST DRILLS BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8496397 ↗InjuryMar 18, 2019Break; Break
IT WAS REPORTED A TWIST DRILL BROKE. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8428560 ↗InjuryFeb 25, 2019Break; Break
IT WAS REPORTED THE TWIST DRILL BROKE. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8367373 ↗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 8298211 ↗InjuryFeb 1, 2019Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED A TWIST DRILL BROKE DURING USE. ALL PIECES WERE REMOVED. PER IFU 90-274-92-40 FOR THE TWIST DRILL "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 5000 RPM."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8298203 ↗InjuryDec 3, 2018Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED THAT A TWIST DRILL BROKE DURING USE. A PORTION REMAINED IMPLANTED. PER IFU (B)(4) FOR THE TWIST DRILL "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 5000 RPM."
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8126150 ↗InjuryNov 16, 2018Break; Break
IT WAS REPORTED A TWIST DRILL BROKE DURING USE. A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8077751 ↗InjuryNov 5, 2018Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE DURING USE. A PORTION REMAINED IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8038596 ↗InjuryNov 5, 2018Break; Break
IT WAS REPORTED THAT A BROKEN TWIST DRILL WAS REMOVED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8038571 ↗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 8038561 ↗InjuryOct 15, 2018Break; Break
IT WAS REPORTED A TWIST DRILL BROKE DURING USE. A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7966119 ↗InjuryOct 5, 2018Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED THAT A TWIST DRILL BROKE DURING USE. THE TWIST DRILL WAS REMOVED FROM THE PATIENT. THE TWIST DRILL WAS BEING USED AT 20,000 RMPS. IT IS STATED IN IFU 90-274-92-40 "FOR TWIST DRILLS WITH AN OVERALL LENGTH OF GREATER THAN 50MM, AN APPROPRIATE BURR GUARD OR DRILL GUIDE SHOULD BE USED AT ALL TIMES."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7939734 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page