EVOS 71174927Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885556387641), received between Mar 29, 2017 and May 25, 2026 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2026Fracture

  IT WAS REPORTED THAT, DURING A PROXIMAL TIBIA ORIF SURGERY, THE TIP OF ONE (1) T7 DRIVER SHAFT W/AO QC BROKE OFF WHILE PUTTING IN A SCREW. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273369 ↗
• MalfunctionJul 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, WHILE INSERTING A SCREW INTO A PLATE WITH THE T7 DRIVER SHAFT W/AO QC THE HEAD OF THE DRIVER BROKE. THE PIECES WERE REMOVED AND CONFIRMED VIA C-ARM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19675040 ↗
• MalfunctionMay 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE T7 DRIVER SHAFT W/AO QC BROKE OUTSIDE THE PATIENT. NO PIECES FELL INTO PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14362921 ↗
• InjuryJan 3, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A T7 DRIVER SHAFT WITH AO QUICK CONNECT SNAPPED WHILE INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142293 ↗
• MalfunctionFeb 17, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, SCREWDRIVERS ARE WORN DOWN SO THEY DON'T FIT IN THE SCREWS PROPERLY. THIS WAS NOTICED DURING INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11341053 ↗
• MalfunctionJan 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T7 DRIVER SHAFT W/AO QC IS NOT CAPTURING THE SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210997 ↗
• MalfunctionJan 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T7 DRIVER SHAFT W/AO QC IS NOT CAPTURING THE SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210962 ↗
• MalfunctionJan 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T7 DRIVER SHAFT W/AO QC IS NOT CAPTURING THE SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210913 ↗
• MalfunctionJan 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T7 DRIVER SHAFT W/AO QC IS NOT CAPTURING THE SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210887 ↗
• MalfunctionJan 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T7 DRIVER SHAFT W/AO QC IS NOT CAPTURING THE SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210867 ↗
• MalfunctionJan 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T7 DRIVER SHAFT W/AO QC IS NOT CAPTURING THE SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210847 ↗
• MalfunctionJan 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T7 DRIVER SHAFT W/AO QC IS NOT CAPTURING THE SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210774 ↗
• MalfunctionJan 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T7 DRIVER SHAFT W/AO QC IS NOT CAPTURING THE SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210738 ↗
• MalfunctionJan 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THET7 DRIVER SHAFT W/AO QC IS NOT CAPTURING THE SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210712 ↗
• MalfunctionJan 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T7 DRIVER SHAFT W/AO QC IS NOT CAPTURING THE SCREW AS IT USED TO. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210686 ↗
• MalfunctionSep 4, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT BOTH OF THE T8 DRIVER SHAFT W/AO QC AND T7 DRIVER SHAFT W/AO QC SHAFTS SLIPPED INSIDE OF THE SCREW RECESSES WHILE TRYING TO REMOVE HARDWARE. OCCURRED DURING USE-INSIDE THE PATIENT. UNKNOWN IF THERE WAS A SMITH AND NEPHEW BACKUP DEVICE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10496980 ↗
• MalfunctionMay 28, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGERY THE END OF THE DRIVER WAS FOUND TO BE ROUNDING OFF. IT HAPPENED OUTSIDE THE PATIENT. NO PATIENT AFFECTATION. NO DELAY REPORTED. THE PROCEDURE COULD BE FINISHED USING AN S&N BACKUP DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10099246 ↗
• InjurySep 9, 2019Break; Break

  IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF DURING SURGERY AND REMAINED INSIDE THE PATIENT. NO DELAY REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8976419 ↗
• InjuryMar 29, 2017Fracture; Fracture

  IT WAS REPORTED THE TIP OF THE DRIVER BROKE DURING A SURGERY AND WAS LEFT IN THE HEAD OF THE SCREW IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6444098 ↗