PathFinder NXT® 3572-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024336513), received between Aug 21, 2024 and Dec 12, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (3 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.

• MalfunctionDec 12, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THREE CLOSURE TOPS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THE STRIPPED CLOSURE TOPS WERE REMOVED AND REPLACED. IT WAS SUSPECTED THAT THE TORQUE WRENCH WAS OVER-TORQUEING AND CONTRIBUTED TO THE DAMAGE. THERE WAS A 30 MINUTE DELAY BUT NO PATIENT IMPACT. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918176 ↗
• MalfunctionNov 26, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING THE FINAL TIGHTENING OF A SET SCREW, THE TORQUE WRENCH CLICKING SOUND WAS SLUGGISH AND THE SET SCREW WAS DAMAGED. THE SET SCREW WAS REPLACED, HOWEVER THE SECOND AND THIRD SET SCREWS WERE DAMAGED IN THE SAME WAY. THE BONE SCREW WAS ALSO DAMAGED, AND REMOVED AND REPLACED WITH A NEW SCREW, AND THE FINAL TIGHTENING OF THE SET SCREW WAS SUCCESSFUL. THIS CAUSED A 15 MINUTE DELAY TO THE PROCEDURE, HOWEVER THERE WAS NO PATIENT IMPACT. THIS IS REPORT THREE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787877 ↗
• MalfunctionNov 20, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY, A PATHFINDER TORQUE RATCHET HANDLE WAS NOT ABLE TO TIGHTEN CLOSURE TOPS PROPERLY, STRIPPING THE THREADS ON FIVE CLOSURE TOPS AND STRIPPING THE INNER DRIVE HEXAGON ON THREE MORE. A PEDICLE SCREW WAS ALSO REPORTED TO HAVE DISASSEMBLED DURING THE SURGERY. THERE WAS NO PATIENT HARM, HOWEVER THERE WAS A 30 MINUTE PROCEDURAL DELAY AS A RESULT OF THIS. THIS IS REPORT TEN OF TEN FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737165 ↗
• MalfunctionAug 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A SURGEON COMPLAINED THAT TWO T-HANDLE TORQUE RATCHETING HANDLES DID NOT APPLY ENOUGH TORQUE INTRA-OPERATIVELY. THE SURGERY WAS ABLE TO BE COMPLETED USING THE SAME TOOL WITH GREATER FORCE, AND THERE NO PATIENT IMPACT; HOWEVER, THERE WAS A 10 MINUTE DELAY ON SURGERY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025721 ↗
• MalfunctionAug 21, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A SURGEON COMPLAINED THAT TWO T-HANDLE TORQUE RATCHETING HANDLES DID NOT APPLY ENOUGH TORQUE INTRA-OPERATIVELY. THE SURGERY WAS ABLE TO BE COMPLETED USING THE SAME TOOL WITH GREATER FORCE, AND THERE NO PATIENT IMPACT; HOWEVER, THERE WAS A 10 MINUTE DELAY ON SURGERY. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020634 ↗