EVOS 71174920Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556387290), received between Feb 17, 2021 and Aug 23, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIXED HANDLE T6 SCREW DRIVER TIP BROKE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608225 ↗
• 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 11341081 ↗
• MalfunctionFeb 17, 2021Naturally 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 11340239 ↗