N/A 9734302Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994724052), received between Mar 13, 2017 and Jun 11, 2025 — classified as 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22189752 ↗
• MalfunctionFeb 26, 2020Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TAP NEVER WENT INTO THE WASH.

  Patient problems: No Patient Involvement

  MAUDE report 9756631 ↗
• MalfunctionFeb 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A TAP INSTRUMENT WAS FOUND TO BE DAMAGED IN THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8334238 ↗
• MalfunctionMar 13, 2017Complete Blockage; Complete Blockage

  A MEDTRONIC REPRESENTATIVE REPORTED THAT A SOLERA 6.5 TAP HAD A GUIDE WIRE STUCK INSIDE. NO PATIENT OR USER HARM REPORTED. THIS ISSUE WAS DISCOVERED OUTSIDE OF SURGICAL USE.

  Patient problems: No Patient Involvement

  MAUDE report 6398498 ↗