EXPert Nail 04.031.938SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982094360), received between Mar 28, 2018 and Sep 9, 2026 — classified as 1 injury, 1 malfunction.

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 18, 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.

• MalfunctionSep 9, 2026Break; Crack; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697325 ↗
• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2018 DUE TO NONUNION OF THE RIGHT FEMORAL SHAFT TO REMOVE THE 8.2 MM TI ADOLESCENT LATERAL ENTRY NAIL AND TWO SCREWS AND REPLACE WITH THE 10 MM TI ADOLESCENT LATERAL ENTRY NAIL. THE 8.2 MM TI ADOLESCENT LATERAL ENTRY NAIL ALONG WITH TWO (2) UNKNOWN SCREWS WERE ORIGINALLY IMPLANTED ON (B)(6) 2017. THE NONUNION WAS DISCOVERED DURING A PATIENT FOLLOW-UP VISIT FROM ORIGINAL SURGERY AND WAS DISCOVERED FROM A VISUAL INSPECTION OF XRAY. THE XRAY IMAGES IS NOT AVAILABLE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS AS PLANNED. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7378227 ↗