EVOS 72468104Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556672815), received between Oct 19, 2020 and Oct 19, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 19, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ORIF DISTAL RADIUS SURGERY, THE LOCKING SCREWS WOULDN'T LOCK INTO THE PLATE, IT WOULD JUST KEEP SPINNING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIGNIFICANT DELAY, USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965901 ↗
• InjuryOct 19, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A PROCEDURE NO LOCKING SCREW WAS INSERTED IN ONE OF THE DISTAL LOCKING HOLES. ONCE REDUCTION WAS RETAINED, THE CORTEX SCREW WAS REMOVED AND A LOCKING SCREW WAS INSERTED. THE LOCKING TABS, HOWEVER, WERE TOO DAMAGED AND NO SCREW COULD BE PLACED IN THAT HOLE. A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10698100 ↗