"1.5MM" SYSTEM TWIST DRILL 01-7149Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00841036013202), received between Aug 20, 2019 and Jul 18, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE DRILL WAS FRACTURED AND RETRIEVED DURING A PROCEDURE. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. 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 22541522 ↗
• MalfunctionAug 27, 2024Fracture; Fracture

  IT IS REPORTED THAT THE DRILL FRACTURED DURING A PROCEDURE. ALL FRAGMENTS WERE RETRIEVED AND NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076136 ↗
• MalfunctionOct 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL FRACTURED WHEN TESTING THE ROTATION. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15528061 ↗
• MalfunctionSep 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO DRILLS FRACTURED DURING DRILLING. THE FRACTURED PARTS OF BOTH DRILLS WERE EMBEDDED IN THE BONE, THE BONE AROUND THE EMBEDDED PARTS WAS SCRAPED OFF, AND ALL THE FRACTURED PARTS WERE REMOVED. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO ADVERSE EVENTS AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434376 ↗
• MalfunctionDec 14, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005530 ↗
• MalfunctionAug 31, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391257 ↗
• MalfunctionJul 27, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12227667 ↗
• MalfunctionJun 22, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12044085 ↗
• MalfunctionMay 24, 2021Fracture; Fracture

  IT WAS REPORTED THE TIP OF THE DRILL WAS MISSING AND IT WAS DISCOVERED UPON RECEIVING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869600 ↗
• MalfunctionJun 29, 2020Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10206383 ↗
• MalfunctionApr 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO DRILL BITS FRACTURED DURING SURGERY. THE SURGEON REPORTED THAT THE FRACTURE OCCURRED AT THE MOMENT OF CONTACT WITH THE BONE, AND THAT THE PATIENT HAD UNUSUALLY HARD BONE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9977129 ↗
• MalfunctionDec 26, 2019Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 9521140 ↗
• MalfunctionAug 30, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8952724 ↗
• MalfunctionAug 20, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8912138 ↗

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