EVOS 71175099Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556651346), received between Sep 13, 2018 and Jun 22, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• MalfunctionJun 22, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A 2.5MM HEX LINEAR DRIVER SHAFT CASE (B)(4) AND A 2.5MM HEX HOLDING SLEEVE CASE (B)(4) WERE NOT CAPTURING. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT. THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042966 ↗
• MalfunctionJun 22, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A 2.5MM HEX LINEAR DRIVER SHAFT CASE (B)(4) AND A 2.5MM HEX HOLDING SLEEVE CASE (B)(4) HAVE NOT BEEN CAPTURING. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL OR THERAPEUTICAL ENVIRONMENT OR NOT. THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042951 ↗
• MalfunctionSep 13, 2018Defective Device; Defective Device

  PROXIMAL TIBIA. DR. (B)(6) USED AN EVOS 8H LATERAL PROXIMAL TIBIA PLATE. WHEN DR. (B)(6) INSERTED THE MOST DISTAL SCREW ON POWER (PERCUTANEOUS), THEN FINAL TIGHTENED ON HAND THE SCREW STRIPPED.

  Patient problems: No Information

  MAUDE report 7875160 ↗