Stainless Steel Guide Wires 01-9473-3115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840194465359), received between Oct 16, 2024 and Apr 28, 2026 — 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 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.

• MalfunctionApr 28, 2026Fracture

  THREADED TIP GUIDE WIRE BROKE OFF IN PATIENT'S HUMERUS. DR. (B)(6) STATES SHE WAS NOT MANIPULATING WIRE TRAJECTORY AND WAS NOT PASSING WIRE THROUGH/AGAINST CORTICAL BONE. THIS WAS THE FIRST PASS WITH THE WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25015764 ↗
• MalfunctionOct 16, 2024Fracture; Fracture

  DR. (B)(6) DESCRIBED TO ME THAT DURING A TRI-PLANE DISTAL TIBIAL FRACTURE HE WAS ATTEMPTING TO PLACE GUIDE WIRES FOR 4.0 MM SCREWS. AFTER PLACING HIS INITIAL GUIDEWIRES INTO THE DISTAL TIBIA, AND ATTAINING ADEQUATE REDUCTION, DR. CARDIN SAYS HE TRIED TO REPLACE OR REDIRECT, ONE OF HIS GUIDEWIRES, AND SUBSEQUENTLY THE GUIDEWIRE BROKE AS SOON AS HE TRIED TO REDIRECT IT WITH THE WIRE DRIVER. HE ALSO STATES THAT MULTIPLE OTHER WIRES HAD BENT SIGNIFICANTLY DURING THIS PROCEDURE, FOUR TO BE EXACT. HE ATTEMPTED TO SWITCH WIRE DRIVERS TO A DIFFERENT SYSTEM TO SEE IF THAT WOULD HELP, AND SUBSEQUENTLY BROKE TWO MORE PINS, LEAVING A PORTION OF ONE OF THE THREADED TIPS OF THE PINS INSIDE THE PATIENT'S DISTAL, TIBIA, AND MAKING IT DIFFICULT TO RETRIEVE THE PART THAT HAD BROKEN OFF. EVEN IN AN ATTEMPT TRYING TO RETRIEVE ONE OF THE PINS THAT HAD SNAPPED OFF WITH A PAIR OF PLIERS, THE TIPS WOULD CONTINUE TO BREAK. ONE WIRE BROKE INTO ABOUT SEVEN PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467639 ↗