Jet-X 71063028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010532084), received between Jul 29, 2024 and Aug 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION SURGERY, ONE (1) JETX 3.5 SHT GRAD STEP DRILL FRACTURED. THE BROKEN PIECE COULD BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750300 ↗
• MalfunctionJul 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN EXTERNAL FIXATION SURGERY, ONE (1) JETX 3.5 SHT GRAD STEP DRILL FRACTURED. THE PIECE WAS RETRIEVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19856049 ↗