TRAUMAONE SYSTEM 46-1006 (UDI 00841036137410)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841036137410), received between Apr 29, 2019 and Sep 12, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL FRACTURED DURING USE. THE SURGEON RETRIEVED ALL THE DEBRIS AND USED ANOTHER DRILL TO COMPLETE THE OPERATION. THERE WAS NO SERIOUS INJURY AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200988 ↗
• MalfunctionMar 11, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875199 ↗
• MalfunctionApr 1, 2020Fracture; Fracture

  IT WAS REPORTED THE DRILL BIT FRACTURED WHILE DRILLING A PILOT HOLE INTO THE PATIENT'S MANDIBLE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DRILL BIT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9910393 ↗
• MalfunctionJan 14, 2020Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9586527 ↗
• MalfunctionDec 5, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9418465 ↗
• InjuryApr 29, 2019Fracture; Fracture

  IT WAS REPORTED THAT TWO (2) DRILLS FRACTURED IN THE PATIENT'S MANDIBLE DURING A SURGERY FOR THE REPAIR OF A MANDIBULAR FRACTURE. THE SURGERY WAS DELAYED ONE AND A HALF HOURS DUE TO ADDITIONAL TIME NEEDED TO REMOVE THE PLATE AND SCREWS, BURR THE PATIENT'S BONE TO REMOVE THE FRACTURED PIECE, AND REPLACEMENT OF THE PLATE AND SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8560989 ↗

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