"1.5MM" SYSTEM TWIST DRILL 01-7146Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00841036013189), received between Apr 17, 2019 and Feb 1, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL FRACTURED DURING USE. ALL PIECES WERE REMOVED FROM THE PATIENT'S WOUND. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628585 ↗
• 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 15434365 ↗
• MalfunctionAug 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT A DRILL TIP WAS BROKEN AND BURIED WITHIN A BONE DURING A PROCEDURE. THE DRILL TIP WAS RECOVERED. 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 15300783 ↗
• MalfunctionJun 27, 2022Fracture; Fracture

  IT IS REPORTED THAT THE DRILL TIP BROKE DURING A PROCEDURE WITH NO HARM TO THE PATIENT. 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 14830967 ↗
• MalfunctionApr 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THAT DRILL TIPS BROKE WHEN FIXING THE PLATE WITH A SCREW. THERE WAS A THIRTY MINUTE DELAY WHILE BROKEN DRILL TIPS WERE RETRIEVED FROM THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073670 ↗
• MalfunctionApr 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THAT DRILL TIPS BROKE WHEN FIXING THE PLATE WITH A SCREW. THERE WAS A THIRTY MINUTE DELAY WHILE BROKEN DRILL TIPS WERE RETRIEVED FROM THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073658 ↗
• MalfunctionJan 5, 2021Fracture; Fracture

  IT WAS REPORTED THE TAP BROKE WHILE THE SURGEON WAS CUTTING THE TAP RESULTING IN A SURGICAL DELAY GREATER THAN THIRTY MINUTES. THE SURGEON DRILLED A HOLE AROUND THE BROKEN TAP WITH A TWIST DRILL AND USED PLIERS TO REMOVE THE TAP. IMAGING REVEALED THERE WAS NO FRAGMENT IN THE PATIENT'S BODY. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11121464 ↗
• 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 10896369 ↗
• InjurySep 2, 2020Fracture; Fracture

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10482087 ↗
• MalfunctionAug 5, 2020Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10368991 ↗
• MalfunctionJun 17, 2020Fracture; Fracture

  IT WAS REPORTED THE DRILL AND TAP FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DRILL AND TAP. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10165571 ↗
• InjuryApr 17, 2019Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 8523049 ↗
• InjuryApr 17, 2019Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 8523034 ↗

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