EVOS 71175094Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556635926), received between Jan 22, 2020 and Jan 22, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2020Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING SURGERY A PF PIN WAS INSERTED INTO THE HARD CORTICAL BONE, AT THAT MOMENT THE PLATE POSITIONING WASN'T RIGHT, SO THE PIN WAS REMOVED AND ADJUSTED. IT WAS ADVISED THE PRODUCT IS SINGLE-USE, BUT THE SAME PIN WAS DRIVEN INTO A NEW POSITION HIGHER UP THE HARD CORTICAL TIBIA BONE, UPON ATTEMPTING TO REMOVE THE PIN IT SNAPPED AND LEFT 25MM OF STEEL IN THE LEG. NO DELAY IN THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 9615503 ↗