"1.0MM" SYSTEM TWIST DRILL 01-7423Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841036014209), received between Mar 27, 2023 and Oct 4, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867776 ↗
• InjuryMar 27, 2023Fracture; Fracture

  IT IS REPORTED THAT THE TIP OF THE TWIST DRILL FRACTURED OFF DURING A PROCEDURE. IT IS UNKNOWN IF ANY FRAGMENTS REMAIN IN THE PATIENT. THERE WAS A TWO TO THREE MINUTE DELAY IN THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 16619225 ↗

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