EVOS 71174933Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556387948), received between Sep 4, 2020 and Nov 11, 2025 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ELBOW ORIF PROCEDURE, THE STAR PORTION OF ONE (1) T8 DRIVER SHAFT W/AO QC BROKE OFF DURING SCREW INSERTION BECOMING UNUSABLE. NO FRAGMENTS FELL IN THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525780 ↗
• MalfunctionApr 6, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, PRIOR TO SURGERY, TWO OF THE T8 DRIVER SHAFT W/AO QC WERE NOTICED TO BE WORN. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICES, WITH NO SURGICAL DELAY OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617548 ↗
• MalfunctionApr 6, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, PRIOR TO SURGERY, TWO OF THE T8 DRIVER SHAFT W/AO QC WERE NOTICED TO BE WORN. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICES, WITH NO SURGICAL DELAY OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617544 ↗
• 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 11341069 ↗
• MalfunctionFeb 15, 2021Fitting Problem; Naturally Worn; Fitting Problem; Naturally Worn

  IT WAS REPORTED THAT, DURING A UNKNOWN PROCEDURE THE T8 DRIVER SHAFT W/AO QC WAS NOTICED WORN OUT AND NO LONGER FITS IN THE SCREW HEAD PROPERLY. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS OR EQUAL TO 30MIN USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326797 ↗
• MalfunctionJan 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 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 11227210 ↗
• MalfunctionJan 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 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 11227158 ↗
• MalfunctionJan 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 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 11227097 ↗
• MalfunctionJan 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 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 11227047 ↗
• MalfunctionJan 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 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 11227000 ↗
• MalfunctionJan 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 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 11226924 ↗
• MalfunctionJan 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 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 11226884 ↗
• MalfunctionJan 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 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 11226717 ↗
• MalfunctionJan 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 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 11226625 ↗
• MalfunctionJan 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 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 11226392 ↗
• InjuryDec 31, 2020Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, THE BIT OF T8 SCREWDRIVER SHAFT SHORT BROKE. NO INJURY CAME TO THE PATIENT AND NO DELAY WAS CAUSED IN THE CASE. THE PROCEDURE WAS COMPLETED WITH A SN BACK UP DEVICE, THE LONGER VERSION OF THIS DRIVER. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103305 ↗
• 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 10496964 ↗