TRAUMAONE SYSTEM 46-1004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841036128029), received between Dec 26, 2019 and May 27, 2025 — classified as 3 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT STAFF IDENTIFIED A FRACTURED DRILL BEFORE SURGERY DURING PREPARATION FOR AN INITIAL PROCEDURE. THE DRILL HAD BEEN USED MULTIPLE TIMES, AND THE FRACTURE WAS PRESENT BEFORE STERILIZATION, WHILE STILL AT THE HOSPITAL. THE DEVICE WAS REPORTED TO HAVE BEEN USED AS A LOANER AND WAS RETURNED TO THE DISTRIBUTOR FOLLOWING USE. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088121 ↗
• MalfunctionNov 15, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696011 ↗
• MalfunctionDec 26, 2019Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521174 ↗

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