Invictus 17111Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00190376192710), received between Oct 6, 2020 and Sep 24, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891994 ↗
• MalfunctionSep 14, 2026Break; Material Separation

  It was reported that the tip of the driver broke off during a case. The tip was retrieved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50759572 ↗
• MalfunctionSep 14, 2026Break; Material Separation

  It was reported that the tip of the driver broke off during a case. The tip was retrieved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758627 ↗
• MalfunctionJul 27, 2026Break; Material Separation

  It was reported that the tip of the driver broke off during a case. The tip was retrieved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008555 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT THE DRIVER IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280627 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT THE DRIVER IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280578 ↗
• MalfunctionMar 13, 2026Break; Material Separation

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN INSERTING A SCREW INTO DENSE BONE. THE TIP WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590602 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23929486 ↗
• MalfunctionJun 11, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE DRIVER WAS NOT FULLY ENGAGED WITH THE SCREW TULIP HEAD AND WAS USED AS A STAB AND GRAB DRIVER WHEN THE TIP BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187844 ↗
• MalfunctionMay 16, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TIP OF THE DRIVER HAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039622 ↗
• MalfunctionFeb 13, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF INTO A SCREW DURING A CASE. THE SCREW WITH THE DRIVER TIP WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378767 ↗
• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER IS BROKEN OFF AND WAS NOTICED AFTER STERILE PROCESSING. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767306 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE IN A SCREW WHEN REMOVING THE SCREW FOR BETTER VISIBILITY. THERE WAS NO REPORT OF PATIENT SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322858 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF. THERE IS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183695 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT THE TIP BROKE OFF OF THE DRIVER. THE TIP WAS RETRIEVED FROM THE PATIENT. THERE WAS NO REPORT OF PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067699 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THE TIP OF THE DRIVER SHEARED OFF. IT WAS RETRIEVED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999284 ↗
• MalfunctionAug 16, 2023Fracture; Fracture

  IT WAS REPORTED THE DISTAL TIP OF THE SCREWDRIVER SHEARED OFF DURING SURGERY. ALL PIECES WERE RETRIEVED AND DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559440 ↗
• MalfunctionMay 12, 2022Fracture; Fracture

  WHILE TRYING TO REMOVE A SCREW, THE TIP OF THE DRIVER BROKE OFF AND THE TOWER OF THE SCREW POPPED. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14382293 ↗
• MalfunctionApr 16, 2021Use of Device Problem; Separation Problem

  THE TIP OF THE MIS REDUCTION POLYAXIAL SCREWDRIVER SHEARED OFF WHEN ATTEMPTING TO IMPLANT A PEDICLE SCREW. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682723 ↗
• MalfunctionOct 6, 2020Improper or Incorrect Procedure or Method

  THE SURGEON BROKE THE TIP OFF AN MIS REDUCTION SCREWDRIVER DURING SCREW INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 10638791 ↗