EVOS 71175074Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556636060), received between Sep 10, 2020 and May 20, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2024Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT, DURING THE DISTAL TIBIA OSTEOSYNTHESIS SURGERY, ONE (1) EVOS SM 2.5MM TAPERED HEX DR SHAFT-LONG WAS USED TO PLACE THE COMPRESSION SCREWS AND THE PLATE, THESE SCREWDRIVER WAS A LITTLE SMOOTH, AND DID NOT HOLD THE SCREWS WELL, THEY FELL OUT. ONE (1) EVOS 3.5MM X 32MM CTX SCR S-T; ONE (1) EVOS 3.5MM X 48MM CTX SCR S-T; ONE (1) EVOS 3.5MM X 22MM CTX SCR S-T AND ONE (1) EVOS 3.5MM X 28MM CTX SCR S-T ROLLED WHEN THEY WERE FIRST USED, EXCESSIVE FORCE WAS USED SO THAT THE SCREWS COULD ENTER THE HOLE, BUT THEY ROLLED AND THEIR HEADS WERE DAMAGED SO THEY COULD NOT ENTERED COMPLETELY. THEY WERE REMOVED AND REPLACED WITH A NEW SCREW. OTHER HOLES HAD TO BE MADE IN DIFFERENT DIRECTIONS THAN THE HOLES MADE INITIALLY. THE PATIENT'S HEALTH CONDITION IS STABLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Perforation

  MAUDE report 19353556 ↗
• MalfunctionFeb 18, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS SCREWDRIVER WAS WORN DOWN. THIS WAS DISCOVERED DURING INSPECTION IN CPD, THIS DID NOT HAPPEN DURING SURGERY. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346216 ↗
• MalfunctionNov 23, 2020Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT UPON INSPECTION, THIS ITEM NO LONGER FUNCTIONS PROPERLY. THE DRIVER IS STRIPPED AND DOES NOT BITE WHEN DRIVING SCREWS. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10883922 ↗
• MalfunctionSep 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION PROCESS THE FOLLOWING DEVICES WERE FOUND TO BE STRIPPED: EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DRIVER (CASE-2020-00014793-1), EVOS SM 2.5MM TAPERED HEX DRIVER SHAFT-SHORT (CASE-2020-00014793-2), AND EVOS SM 2.5MM TAPERED HEX DRIVER SHAFT-LONG (CASE-2020-00014793-3). THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10514063 ↗