N/A 960-524 (UDI 00673978089966)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00673978089966), received between Oct 25, 2016 and Jul 27, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionJul 27, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE DRILL BIT GUIDE WAS REPORTED TO BE DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 10329365 ↗
• MalfunctionOct 25, 2016Break; Material Deformation; Break; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A PELVIC FIXATION PROCEDURE, THE SITE'S DRILL BIT GUIDE WAS BROKEN. THIS BIT WAS CONNECTED TO A NON-MEDTRONIC DRILL. WHEN PRESSING INTO THE PELVIS, THE TIP OF THE BIT BROKE OFF INSIDE THE PELVIC BONE. THE SURGEON SUCCESSFULLY REMOVED THE BROKEN PIECE FROM THE BONE. THE SURGEON OPTED TO CONTINUE THE PROCEDURE USING A NON-NAVIGATED NON-MEDTRONIC DRILL BIT. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6055993 ↗