"1.5MM" SYSTEM 01-7142Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841036013141), received between Jun 3, 2020 and Mar 5, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A DRILL WAS FRACTURED DURING USAGE BUT ALL FRAGMENTS WERE RETRIEVED. 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 21529334 ↗
• MalfunctionNov 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT A DRILL BROKE DURING USE. THE FRAGMENTS WERE RECOVERED. NO FRAGMENTS REMAIN IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662418 ↗
• MalfunctionAug 5, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905425 ↗
• MalfunctionSep 14, 2020Flaked; Flaked

  IT WAS REPORTED THAT PAINT PEELED OFF A DRILL BIT WHILE THE SURGEON WAS PREPARING A PILOT HOLE IN THE LOWER EDGE OF THE PATIENT'S ORBIT. THE PEELED PIECE OF PAINT WAS REMOVED WITH FORCEPS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10528456 ↗
• InjuryJun 3, 2020Flaked; Flaked

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10115400 ↗

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