N/A 9734410 (UDI 00613994724007)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994724007), received between Nov 10, 2016 and Oct 19, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN THE STERILE PROCESSING DEPARTMENT (SPD), THE TOP OF THE RATCHETING HANDLE WAS NOTED TO BE MISSING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10698334 ↗
• MalfunctionMay 24, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE HAMMERABLE PART ON THE BACK OF THE HANDLE WAS BROKEN. THIS ISSUE COULD NOT BE LINKED TO A SPECIFIC SURGERY OR STERILIZATION PROCESS. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8642789 ↗
• MalfunctionMay 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION FROM A USER FACILITY REGARDING A NAVIGATION INSTRUMENT BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. THE CALLER INDICATED THAT THE RATCHETING EGG HANDLE BROKE DURING THE PROCEDURE. THE CALLER INDICATED THAT THE LIKELY CAUSE WAS THAT THE RATCHET WAS TOO BIG OR THE CENTER PART OF THE HANDLE WAS NOT STRONG ENOUGH. THE HANDLE WAS REPLACED AND THERE WAS NO DELAY OR IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8606044 ↗
• MalfunctionOct 10, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TOP OF THE RATCHETING HANDLE WAS MISSING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 7954049 ↗
• MalfunctionNov 10, 2016Break; Device Damaged by Another Device; Material Deformation; Break; Device Damaged by Another Device; Material Deformation

  A SITE PHYSICIAN REPORTED THAT, WHILE IN A SPINE PROCEDURE, THEIR EGG HANDLE IMPACTOR WAS BROKEN. THE DAMAGE OCCURRED DURING A NAVIGATION SYSTEM AND IMAGING SYSTEM DEMO PROCEDURE. THE SURGEON HIT THE IMPACTOR 6 - 8 TIMES WITH A HAMMER 280 GR. BEFORE IT BROKE. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6092433 ↗