EVOS 72468304Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556672877), received between Aug 14, 2020 and Oct 21, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionOct 21, 2025Degraded; Degraded

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHILE ONE (1) EVOS VOLAR PLATE 4H L WDE 56MM WAS LOCKED WITH A 2.4 MM SCREW, WHEN THE SCREW WAS SENT THROUGH THE SAME HOLE FOR THE SECOND TIME TO CORRECT ITS ANGLE, THE SCREW HOLE BECAME WORN, ALLOWING THE SCREW TO PASS COMPLETELY THROUGH THE HOLE. THE PROCEDURE WAS COMPLETED USING THE SAME S+N PRODUCT. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347993 ↗
• InjuryAug 14, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF LEFT DISTAL RADIUS THE RADIAL STYLOID LOCKING PEG IN THE MOST DISTAL ROW OF THE PLATE WAS PLACE SUCCESSFULLY. A SECOND SCREW HOLE WAS MADE PROXIMAL TO THIS AND AN ATTEMPT WAS MADE TO INSERT A LOCKING PEG AT WHICH POINT THE SURGEON CLAIMED TO ENCOUNTER DIFFICULTY IN BEING ABLE TO ENGAGE THE THREADED HEAD OF THE PEG WITH THE PETALS IN THE PLATE. SEVERAL ATTEMPTS WERE MADE BEFORE THE SURGEON DECIDED TO LEAVE THE HOLE EMPTY. DURING SURGERY THE DRILL BLOCK GUIDE WAS NOT USED. ANOTHER PLATE WAS TAKEN FROM THE SET AND THE SURGEON TRIED TO INSERT A LOCKING PEG INTO THE DISTAL ROW OF THE PLATE AT WHICH TIME HE WAS ABLE TO DRIVE THE PEG COMPLETELY THROUGH THE PLATE. HOWEVER THIS WAS ON THE THIRD ATTEMPT AND WITH SOME FORCE. THE SURGEON THEN WENT ON TO TRY DIFFERENT HOLES WITHIN THE PLATE USING DIFFERENT PEGS WITH THE SAME RESULT AFTER MORE THAN ONE ATTEMPT TO LOCK, UNLOCK AND THEN DRIVE THE PEG THROUGH THE PLATE HOLE. THE PLATE BEING RETURNED SHOWS THAT IN EACH OF THE DISTAL HOLES THE PETALS HAVE BEEN DEFORMED/DESTROYED IN THE PROCESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10408955 ↗