EVOS 71175098Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556651339), received between Sep 13, 2018 and Dec 19, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A 2.5MM HEX LINEAR DRIVER SHAFT BROKE. IT IS UNKNOWN IF ANY PIECES FELL INTO PATIENT. IT IS UNKNOWN IF THERE WAS ANY DELAY, BUT THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20977250 ↗
• MalfunctionOct 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE 2.5MM HEX LINEAR DRIVER SHAFT BROKE WHEN DRIVING THE SCREW. IT IS UNKNOWN IF ANY PIECE FELL INSIDE PATIENT ANATOMY. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358475 ↗
• MalfunctionApr 8, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A INTERNAL FIXATION ONE (1) 2.5MM HEX LINEAR DRIVER SHAFT 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 19062602 ↗
• MalfunctionMay 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE END OF A 2.5MM HEX LINEAR DRIVER SHAFT BROKE WHEN PUTTING IN A SCREW. THE BROKEN PIECE WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS RESUMED, WITHOUT DELAYS, USING A S+N AO QUICK CONNECT DRIVE FROM THE SMALL EVOS SET. NO INJURIES WERE REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928311 ↗
• MalfunctionJan 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, WHEN HAND TIGHTENING A SCREW, THE HEX HEAD OF ONE (1) 2.5MM HEX LINEAR DRIVER SHAFT BROKE OFF. THE BROKEN PIECE WAS RETRIEVED BY TWEEZERS. 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 16256160 ↗
• MalfunctionDec 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THAT THE TIP OF ONE (1) 2.5MM HEX LINEAR DRIVER SHAFT BROKE DURING PLATE REMOVAL CASE. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. 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 16007162 ↗
• MalfunctionSep 3, 2020Break; Break

  IT WAS REPORTED THAT THE HEAD OF THE 2.5MM HEX LINEAR DRIVER SHAFT WAS DISCOVERED TO BE BROKEN. THIS WAS DISCOVERED DURING INSTRUMENT INSPECTION AND NO CASE WAS INVOLVED. THERE WAS NO SURGICAL DELAY OR PATIENT HARM REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10490913 ↗
• MalfunctionSep 13, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT IN THE PROXIMAL TIBIA THE DOCTOR USED AN EVOS 8H LATERAL PROXIMAL TIBIA PLATE. WHEN DOCTOR INSERTED THE MOST DISTAL SCREW ON POWER (PERCUTANEOUS), THEN FINAL TIGHTENED ON HAND THE SCREW STRIPPED.

  Patient problems: No Information

  MAUDE report 7875161 ↗