Invictus 17110Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00190376192680), received between Apr 6, 2022 and Sep 1, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Break; Material Separation

  It was reported that the tip of the driver broke off when final tightening a screw. The driver tip was only engaged with the screw core without locking the screw head to the driver. The tip was retrieved, and a second driver was used successfully.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50544631 ↗
• MalfunctionMay 5, 2026Break; Material Separation

  IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF INTO THE SCREW SHANK DURING INSERTION OF THE RIGHT S2AI SCREW. THE SCREW AND DRIVER TIP WERE REMOVED, AND A NEW SCREW WAS PLACED SUCCESSFULLY. THE DRIVER USED TO INSERT THE LEFT S2AI SCREW WAS THEN CHECKED AND ALSO DISCOVERED TO HAVE THE TIP BROKEN OFF INTO THE SHANK. THE TIP WAS REMOVED USING A THIN WIRE, AND THE SCREW REMAINED IN THE PATIENT. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25087206 ↗
• MalfunctionMay 5, 2026Break; Material Separation

  IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF INTO THE SCREW SHANK DURING INSERTION OF THE RIGHT S2AI SCREW. THE SCREW AND DRIVER TIP WERE REMOVED, AND A NEW SCREW WAS PLACED SUCCESSFULLY. THE DRIVER USED TO INSERT THE LEFT S2AI SCREW WAS THEN CHECKED AND ALSO DISCOVERED TO HAVE THE TIP BROKEN OFF INTO THE SHANK. THE TIP WAS REMOVED USING A THIN WIRE, AND THE SCREW REMAINED IN THE PATIENT. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25087158 ↗
• MalfunctionAug 19, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TIP OF THE DRIVER WAS DISCOVERED BROKEN OFF AFTER A CASE. THE TIP WAS NOT LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842547 ↗
• 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 22350636 ↗
• MalfunctionMay 20, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056611 ↗
• MalfunctionMay 12, 2025Break; Material Separation; Break; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003358 ↗
• MalfunctionDec 13, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN LOADING AND UNLOADING A SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925663 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHEN INSERTING A SCREW. THE TIP WAS RETRIEVED FROM THE PATIENT. THERE IS NO REPORT OF SYMPTOMS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588834 ↗
• MalfunctionOct 9, 2023Fracture; Fracture

  IT WAS REPORTED THE TIP OF THE SCREWDRIVER SHEARED OFF DURING USE. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17896554 ↗
• MalfunctionJul 24, 2023Break; Break

  THE SCREWDRIVER TIP IS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17383674 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED THE TIP OF TWO SCREWDRIVERS SHEARED OFF WHILE TRYING TO CHANGE THE TRAJECTORY OF A POLYAXIAL SCREW IMPLANTED IN CORTICAL BONE. THE TIP OF THE FIRST DRIVER WAS RETRIEVED. THE TIP OF THE 2ND DRIVER REMAINS IN THE POLYAXIAL SCREW WHICH WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO IMPACT TO THE PATIENT NOR A DELAY IN SURGERY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453531 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED WHILE TRYING TO REMOVE PREVIOUSLY IMPLANTED HARDWARE DUE TO A NON-UNION OF THE FUSION, THE TIP OF THE SCREWDRIVER BROKE OFF. THE TIP WAS RETRIEVED. THIS DID NOT CAUSE A DELAY IN SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273777 ↗
• MalfunctionDec 13, 2022Break; Break

  WHILE TRYING TO REMOVE PREVIOUSLY IMPLANTED HARDWARE (NON-ALPHATEC PRODUCT), THE TIP OF THE DRIVER SHEARED OFF. THE TIP WAS RETRIEVED FROM THE PATIENT. THIS IS REPORT 2 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973466 ↗
• MalfunctionSep 24, 2022Break; Break

  WHEN THE SURGEON WAS INSERTING A SCREW, THE DISTAL TIP OF THE DRIVER BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15479628 ↗
• MalfunctionApr 6, 2022Break; Break

  THE DISTAL TIP OF THE SCREWDRIVER BROKE OFF. THE SCREWDRIVER IS NO LONGER ABLE TO GRAB ONTO THE SCREW. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14028904 ↗