LEVEL ONE 25-452-07-91Recalls & reported problems
KLS-Martin L.P. · TWIST DRILL, J NOTCH, 7 MM STOP · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This KLS-Martin twist drill is a surgical drilling bit. Reports mostly describe the drill breaking during surgery with a piece left in the patient. There are 25 reports that name its identifier, with no deaths and 25 injuries. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00888118040985), received between May 7, 2018 and Jan 28, 2026 — classified as 25 injuries.
The most frequently reported specific device problem is “Break” (19 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
- Break19
- Fracture6
- Use of Device Problem1
Patient problems
- Device Embedded In Tissue or Plaque22
- Impaired Healing1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 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 24203527 ↗InjuryJan 21, 2026Fracture
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 24136427 ↗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 23760863 ↗InjurySep 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 23010168 ↗InjuryJul 30, 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 22668283 ↗InjuryMar 5, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT CONFIRMED ON X-RAY REMAINS FIRMLY IMPLANTED WITHOUT PLANS FOR REMOVAL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21529164 ↗InjuryJan 14, 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 21148935 ↗InjuryDec 27, 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 21029624 ↗InjuryJul 18, 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 19772057 ↗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 18530409 ↗InjuryJun 30, 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 17240057 ↗InjuryDec 29, 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 16075306 ↗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 15473414 ↗InjuryAug 27, 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: Device Embedded In Tissue or Plaque
MAUDE report 12377772 ↗InjuryAug 4, 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 12274316 ↗InjuryNov 12, 2020Break; Break
IT WAS REPORTED A TWIST DRILL BROKE DURING USE AND IT IS SUSPECTED THAT A PORTION REMAINED IMPLANTED. THE REPORTED RPMS EXCEEDED THE MAXIMUM VALUE FOUND IN THE IFU. 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 10829432 ↗InjuryOct 15, 2020Break; Break
IT WAS REPORTED A TWIST DRILL BROKE DURING USE. A PORTION REMAINS IMPLANTED. THE REPORTED RPMS EXCEEDED THE MAXIMUM VALUE FOUND IN THE IFU. 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 10683424 ↗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 10393725 ↗InjuryJun 24, 2019Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE. A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8728525 ↗InjuryJun 19, 2019Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE. A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8712038 ↗InjuryMar 8, 2019Break; Break
IT WAS REPORTED A TWIST DRILL BROKE AND A PORTION REMAINED IN THE BONE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8404202 ↗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 8298204 ↗InjuryDec 7, 2018Break; Break
IT WAS REPORTED THAT A TWIST DRILL DIAMETER INDICATOR RING BROKE OFF DURING USE AND IT WAS NOT LOCATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8143596 ↗InjuryJun 15, 2018Break; Break
IT WAS REPORTED THE TWIST DRILL BROKE. DOCTOR IS UNSURE IF IT WAS IMPLANTED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7607358 ↗InjuryMay 7, 2018Break; Break
IT WAS REPORTED THAT A TWIST DRILL BROKE AND A PORTION REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7490240 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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