NA 04.033.038SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982270825), received between Aug 11, 2023 and Aug 11, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 18, 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.

• MalfunctionAug 11, 2023Migration; Migration

  IT WAS REPORTED THAT ON JULY 27, 2023 THE SURGEON COMMENTED THAT THE NAIL HAD MEDIALIZED SO MUCH AS IT WAS HUGGING THE MEDIAL CORTEX DISTALLY. THERE WAS NO DIRECT ALLEGATIONS AGAINST THE NAIL, IT WAS MORE ABOUT POSITION. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 10 / TI CANN FRN / PF 380 / RIGHT - SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17508650 ↗