TRAUMAONE SYSTEM 46-1007 (UDI 00841036137427)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841036137427), received between Apr 29, 2019 and Sep 19, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256042 ↗
• MalfunctionSep 19, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE DRILL WAS HANDED TO THE SURGEON, IT WAS DISCOVERED THAT IT WAS BENT. THE SURGEON ATTEMPTED TO STRAIGHTEN THE DRILL, HOWEVER IT FRACTURED. 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 20256011 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION OF A MANDIBULAR FRACTURE, THE DRILL FRACTURED AT THE TIP WHEN THE SURGEON ATTEMPTED TO DRILL A PILOT HOLE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305016 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304975 ↗
• MalfunctionApr 12, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648123 ↗
• MalfunctionApr 12, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648105 ↗
• MalfunctionJul 9, 2020Fracture; Fracture

  IT WAS REPORTED THE DRILL BIT FRACTURED WHEN BEING USED IN COMBINATION WITH A TROCAR ON A MANDIBULAR FRACTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 10252903 ↗
• MalfunctionMar 17, 2020Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9843204 ↗
• MalfunctionDec 31, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9537003 ↗
• MalfunctionDec 26, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521266 ↗
• MalfunctionDec 6, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9428664 ↗
• 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 8560986 ↗

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