N/A 961-584Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00721902467660), received between Jan 5, 2017 and Oct 28, 2019 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SURETRAK DRIVER HAD A BENT TIP. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9244973 ↗
• MalfunctionMar 5, 2018Mechanical Problem; Mechanical Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE CLAMP DRIVER WAS WORN AND WOULD INTERMITTENTLY ENGAGE THE CLAMP. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7314228 ↗
• MalfunctionSep 28, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF SURGERY THE TIP OF THE CLAMP DRIVER WAS OUTWORN. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6902828 ↗
• MalfunctionJul 18, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, OF THE DRIVER FOR THE SURETRAK CLAMP WAS WORN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6721736 ↗
• MalfunctionMay 30, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT A SITE'S SURETRAK2 CLAMP DRIVER HAD STRIPPED SCREW THREADS. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6599588 ↗
• MalfunctionApr 5, 2017Naturally Worn; Naturally Worn

  A MEDTRONIC REPRESENTATIVE REPORTED THAT THE CLAMP DRIVER WAS DAMAGED AND NEEDED TO BE REPLACED. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT.

  Patient problems: No Patient Involvement

  MAUDE report 6462382 ↗
• MalfunctionJan 5, 2017Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  A MEDTRONIC REPRESENTATIVE REPORTED THAT A SITE HAS A STRIPPED SURETRAK2 CLAMP DRIVER. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6227049 ↗
• MalfunctionJan 5, 2017Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  A MEDTRONIC REPRESENTATIVE REPORTED THAT A SITE HAS A STRIPPED SURETRAK2 CLAMP DRIVER. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6226979 ↗
• MalfunctionJan 5, 2017Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  A MEDTRONIC REPRESENTATIVE REPORTED THAT A SITE HAS A STRIPPED SURETRAK2 CLAMP DRIVER. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6226932 ↗