EXPert Nail 04.031.957SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982094537), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionJul 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 ADOLESCENT LATERAL FEMORAL NAILS ARE ON BACK ORDER. THEIR TEAM HAS TRIED TO ESCALATE THE ISSUE PRIOR TO THE ISSUE OVER THE WEEKEND, BUT NO NAILS HAVE BEEN RELEASED YET. 8.2MM & 9.0MM X 340MM (AMONG OTHER SIZES) NAILS WERE UNAVAILABLE DURING A PROCEDURE . HE MEASURED JUST UNDER 360MM & WANTED TO USE A 340MM NAIL. WHEN UNAVAILABLE HE ATTEMPTED TO USE THE 360MM NAIL BUT IT DISTRACTED THE FRACTURE. NAIL HAD TO BE REMOVED, THEY HAD TO REAM TO A LARGER DIAMETER AND USE AN ADULT NAIL, THAT WAS NOT IDEAL FOR THE PATIENT. THERE WAS A SURGICAL DELAY OF 25 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK: REAMERS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 9 TI ADOL LAT ENTRY FEM NL-EX/360/LT-S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961160 ↗