2.0MM SYSTEM 01-9181Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841036016890), received between Jun 29, 2020 and Apr 20, 2023 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K062842); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775176 ↗
• MalfunctionApr 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE DEVICE FRACTURED. SUBSEQUENTLY, THE SURGEON USED A SPARE DRILL TO COMPLETE THE SURGERY. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED FOR THIS EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775175 ↗
• MalfunctionMar 28, 2023Fracture; Fracture

  THE TWO-DRILL TIP WERE BROKEN WHEN USED ON THE MANDIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627385 ↗
• MalfunctionMar 28, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627384 ↗
• MalfunctionMar 27, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618649 ↗
• MalfunctionJan 3, 2023Fracture; Fracture

  IT WAS REPORTED THE DRILL TIP FRACTURED WHEN THE PILOT HOLE WAS DRILLED IN THE MANDIBLE. ALL FRAGMENTS OF THE BROKEN DRILL WERE RECOVERED. OTHER DRILLS WERE USED TO COMPLETED THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085465 ↗
• MalfunctionOct 11, 2022Fracture; Fracture

  IT IS REPORTED THAT DRILLS FRACTURED DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DRILL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579843 ↗
• MalfunctionOct 11, 2022Fracture; Fracture

  IT IS REPORTED THAT DRILLS FRACTURED DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DRILL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579819 ↗
• MalfunctionJun 29, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083938 ↗
• MalfunctionNov 24, 2020Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10895585 ↗
• InjuryJun 29, 2020Flaked; Fracture; Flaked; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10209395 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062842. One submission often covers many models, so check the product and lot details in each record.

• Z-0538-2010 · Nov 6, 2009 · Terminated
  Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218