EVOS 71158103Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556693780), received between Dec 30, 2019 and Jun 24, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

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.

• InjuryJun 24, 2022Flaked; Deformation Due to Compressive Stress; Flaked; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING AN IM NAIL PROCEDURE, WHILE TIGHTENING THE SCREW IN THE UEVOS VOLAR PLATE 3H LEFT STD TI 48MM, THE HOLES OF THE PLATE GOT DAMAGED AND THE ENTIRE SCREW PASSED THROUGH THE PLATE ALONG WITH SOME FRAGMENTS OF METAL. THE SURGERY COULDN'T BE COMPLETED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14808855 ↗
• MalfunctionMay 29, 2020Fitting Problem; Blocked Connection; Fitting Problem; Blocked Connection

  IT WAS REPORTED THAT DURING SURGERY THE SCREWS WOULDN'T LOCK INTO PLATE. OPENED A NEW SET AND USED THE CONTENTS OF THAT S&N SET. NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10101437 ↗
• MalfunctionDec 30, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY AN EVOS WRIST TI 4H STD L VOLAR DISTAL RADIUS PLATE (71158104) WAS USED WITH A 16MM LOCKING SCREW (74412416), BUT THE SCREW FELL THROUGH THE PLATE. THEN, AN EVOS WRIST TI 3H STD L VOLAR DISTAL RADIUS (PLATE 71158103) WITH A NEW 16MM SCREW (74412416) WAS TRIED AND IT HAD THE SAME ISSUE. THE SURGERY WAS COMPLETED USING AN OLD-STYLE VOLAR DISTAL RADIUS SET. ADDITIONALLY, 11MM CORTEX SCREW (74402411) WAS FOUND TO HAVE THE SAME FAILURE AS WELL. FOR THIS EVENT, THERE WAS A DELAY GREATER THAN 30 MIN AND THE PATIENT WAS NOT INJURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9532181 ↗