Invictus 17026Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00190376234175), received between Feb 8, 2022 and Sep 24, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 21 most recent of 21 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 50891272 ↗
• MalfunctionSep 24, 2026Break; Material Separation

  It was reported that the tip broke off during final tightening. The tip was retrieved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885672 ↗
• MalfunctionSep 10, 2026Break; Material Separation

  It was reported that the tip of the driver is broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718143 ↗
• MalfunctionSep 1, 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 50545152 ↗
• MalfunctionAug 26, 2026Break; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457082 ↗
• MalfunctionJun 10, 2026Break; Material Separation

  IT WAS REPORTED THAT THE DRIVER IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458682 ↗
• MalfunctionMar 11, 2026Break; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573132 ↗
• MalfunctionFeb 2, 2026Break; Material Separation

  IT WAS REPORTED THAT THE TIP OF THE DRIVER SHEARED OFF DURING FINAL TIGHTENING. THE TIP WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234920 ↗
• MalfunctionDec 30, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE DRIVER IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926189 ↗
• MalfunctionDec 3, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A TORQUE LIMITING HANDLE FOLLOWED BY A RATCHETING T-HANDLE WERE USED IN CONJUNCTION WITH THE DRIVER TO FINAL TIGHTEN THE SET SCREW WHEN THE TIP OF THE DRIVER BROKE OFF. THE TIP WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709105 ↗
• MalfunctionNov 19, 2025Break; Material Separation; Break; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595200 ↗
• MalfunctionNov 18, 2025Break; Material Separation; Break; 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 23586376 ↗
• MalfunctionJun 27, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350667 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHILE PROVISIONALLY TIGHTENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341473 ↗
• MalfunctionOct 23, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515575 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHILE TIGHTENING DURING A CASE. THE TIP WAS RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20403681 ↗
• MalfunctionAug 28, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087468 ↗
• InjuryJul 24, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF INTO A SET SCREW. THE TIP WAS UNABLE TO BE RETRIEVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19817544 ↗
• MalfunctionJul 19, 2024Break; Break

  IT WAS REPORTED THE TIP OF THE DRIVER BROKE OFF IN A SET SCREW DURING A CASE. THE TIP OF THE DRIVER WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781601 ↗
• MalfunctionJun 27, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624524 ↗
• MalfunctionFeb 8, 2022Fracture; Fracture

  THE DISTAL TIP OF THE DRIVER SHAFT SHEARED OFF DURING FINAL TIGHTENING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481120 ↗