InCompass® 2155-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024398993), received between Aug 29, 2022 and Jan 22, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Material Twisted/Bent

  IT WAS REPORTED THAT A PATHFINDER REMOVAL DRIVER TIP BENT DURING A REVISION CASE. THERE WAS NO PROCEDURAL IMPACT NOR PATIENT HARM, AND THE REVISION PROCEDURE WAS NOT RELATED TO HIGHRIDGE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148397 ↗
• MalfunctionJan 22, 2026Fracture

  IT WAS REPORTED THAT A PATHFINDER REMOVAL DRIVER TIP FRACTURED DURING A REVISION CASE. THERE WAS NO PROCEDURAL IMPACT NOR PATIENT HARM, AND THE REVISION PROCEDURE WAS NOT RELATED TO HIGHRIDGE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148349 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIPS OF THREE SCREW DRIVERS (ONE UNIVERSAL AND TWO UNIVERSAL WITH STANDARD CONNECTIONS) BROKE INTRA-OPERATIVELY WHILE ATTEMPTING TO REMOVE A SCREW THAT HAD BEEN IMPLANTED FOR 16 YEARS. THE SCREW WAS ABLE TO BE REMOVED USING AN ALTERNATIVE METHOD SINCE THE DRIVER ENGAGEMENT FEATURE HAD STRIPPED. THERE WERE NO REPORTED IMPACTS TO THE PATIENT. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871615 ↗
• MalfunctionSep 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF PATHFINDER NXT UNIVERSAL DRIVER TIP DEFORMED DURING REMOVAL OF PATHFINDER HARDWARE DUE TO ADJACENT SEGMENT BREAKDOWN AND EXTENSION OF CONSTRUCT. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23032063 ↗
• MalfunctionMay 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT A DISTRIBUTOR DISCOVERED TWO PATHFINDER UNIVERSAL DRIVERS WITH FRACTURED TIPS ON A SHELF IN THE SPD DEPARTMENT AFTER THEY WERE RETURNED FROM A HOSPITAL. NO INFORMATION REGARDING PATIENT IMPACT WAS PROVIDED WITH THE RETURN. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059628 ↗
• MalfunctionMay 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT A DISTRIBUTOR DISCOVERED TWO PATHFINDER UNIVERSAL DRIVERS WITH FRACTURED TIPS ON A SHELF IN THE SPD DEPARTMENT AFTER THEY WERE RETURNED FROM A HOSPITAL. NO INFORMATION REGARDING PATIENT IMPACT WAS PROVIDED WITH THE RETURN. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059611 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT FIVE PATHFINDER AND SEQUOIA DRIVERS AND REVISION TOOLS WERE DISCOVERED WITH FRACTURED TIPS AT A DISTRIBUTOR. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522322 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT FIVE PATHFINDER AND SEQUOIA DRIVERS AND REVISION TOOLS WERE DISCOVERED WITH FRACTURED TIPS AT A DISTRIBUTOR. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522312 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT FIVE PATHFINDER AND SEQUOIA DRIVERS AND REVISION TOOLS WERE DISCOVERED WITH FRACTURED TIPS AT A DISTRIBUTOR. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT THREE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522303 ↗
• MalfunctionAug 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION SURGERY TO EXTEND THE CONSTRUCT, TWO INCOMPASS DRIVERS FRACTURED WHEN TRYING TO REMOVE THE PREVIOUSLY-INSTALLED CLOSURE TOPS. THERE WERE NO PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15310926 ↗
• MalfunctionAug 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION SURGERY TO EXTEND THE CONSTRUCT, TWO INCOMPASS DRIVERS FRACTURED WHEN TRYING TO REMOVE THE PREVIOUSLY-INSTALLED CLOSURE TOPS. THERE WERE NO PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15310925 ↗