EVOS 71174986Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00885556500590), received between May 1, 2019 and Mar 31, 2026 — classified as 20 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Break” (53 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 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF WHILE ADVANCING THE SCREW. THE TIP WAS RECOVERED AND DISCARDED. 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 24750674 ↗
• MalfunctionMar 14, 2026Fracture

  IT WAS REPORTED THAT THE TIP OF ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF. AS THIS HAPPENED DURING A LAB DEMO, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600351 ↗
• MalfunctionAug 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC SNAPPED WHEN IMPLANTING THE 2.7MM LOCKING SCREW. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862056 ↗
• MalfunctionAug 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY ONE T8 LINEAR DRIVER SHAFT W/ AO QC SNAPPED WHEN IMPLANTING THE 2.7MM LOCKING SCREW, THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A S+N BACK-UP DEVICE AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825110 ↗
• MalfunctionJan 21, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, THE TIP OF ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC BROKE WHEN TIGHTENING A SCREW. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21203582 ↗
• MalfunctionDec 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE T8 LINEAR DRIVER SHAFT W/ AO QC BROKE WHILE INSERTING THE SCREW. NO PIECES FELL INSIDE THE WOUND, SINCE THE BROKEN PIECE FELL IN THE TABLE. 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 21047071 ↗
• MalfunctionMay 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE TIP OF ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19233359 ↗
• MalfunctionApr 8, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A INTERNAL FIXATION ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC WAS TWISTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19063709 ↗
• MalfunctionFeb 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE TIP OF ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF INSIDE THE HEAD OF A SCREW WHILE FINAL TIGHTENING. THE BROKEN TIP WAS REMOVED OUT OF THE HEAD OF THE SCREW WITH A HEMOSTAT. NO BROKEN PARTS WERE LEFT IN THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743572 ↗
• MalfunctionJan 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A T8 LINEAR DRIVER SHAFT W/ AO QC FRACTURED. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED, BUT NO DELAY OR PATIENT HARM OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454090 ↗
• MalfunctionOct 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, A T8 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF INTO THE SCREW HEAD. IT IS UNKNOWN HOW THIS SURGERY WAS FINISHED OR IF THERE WAS A DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856118 ↗
• MalfunctionAug 31, 2023Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT THE END OF THE T8 LINEAR DRIVER SHAFT W/ AO QC WAS TWISTED AND BROKE WHILE TIGHTENING THE SCREWS. ALL PIECES RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666146 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC BROKE. IT IS UNKNOWN HOW THE TREATMENT WAS COMPLETED AND IF ANY DELAY WAS CAUSED DUE TO THIS INCIDENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642027 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THREE (3) T8 LINEAR DRIVER SHAFT W/ AO QC WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF IT CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553462 ↗
• MalfunctionJun 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, A T8 LINEAR DRIVER SHAFT W/ AO QC HEAD BROKE OFF WHEN TIGHTENING. THE INSTRUMENT BROKE INSIDE THE PATIENT AND PIECES WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210936 ↗
• MalfunctionJun 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, WHILE IMPLANTING A 2.7 LOCKING SCREW ON POWER, THE TIP OF A T8 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF. NO PIECES OF THE DRIVER WERE LEFT IN PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182324 ↗
• MalfunctionJun 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE TIGHTENING A SCREW, THE TIP OF THE T8 LINEAR DRIVER SHAFT W/ AO QC SNAPPED OFF. THE TIP WAS RECOVERED FROM THE PATIENT'S BODY. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO OTHER INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164091 ↗
• MalfunctionJun 20, 2023Fracture; Fracture

  IT WAS REPORTED, THAT, DURING AN ANKLE INTERNAL FIXATION. WHEN INSERTING A 2.7 LOCKING SCREW, THE DISTAL TIP OF THE DRIVER BROKE OFF INTO THE TIP OF THE SCREW. THE BROKEN DISTAL TIP WAS RETRIEVED WITH A SET OF PICKUPS. 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 17162285 ↗
• MalfunctionMay 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A T8 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF IN SCREW WHILE TIGHTENING. A BACK-UP OF THE SAME DEVICE WAS USED AND BROKE AS WELL. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING ONE OF THE BROKEN DEVICES. NO INJURY WAS REPORTED DUE TO THIS ISSUE. 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 17007722 ↗
• MalfunctionApr 13, 2023Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA PLATING SURGERY, THE TIP OF ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC WAS BROKEN. 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 16731741 ↗
• MalfunctionApr 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE TIP OF ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690842 ↗
• MalfunctionMar 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE TIP OF ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF. 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 16482374 ↗
• MalfunctionFeb 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, THE TIPS OF ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368308 ↗
• MalfunctionDec 19, 2022Degraded; Fracture; Material Twisted/Bent; Degraded; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, ONE (1) T8 LINEAR DRIVER SHAFT W/ AO QC BROKE, STRIPPED AND BENT WHILE PUTTING THE LAST 2.7 SCREW. THE PROCEDURE WAS RESUMED, USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF A DELAY HAPPENED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. NO FURTHER INFORMATION AVAILABLE AT THE MOMENT. 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 16008645 ↗
• InjuryNov 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE TIP OF THE T8 LINEAR DRIVER SHAFT W/ AO QC BROKE OFF. THE BROKEN PIECE WAS RETRIEVED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15723189 ↗