EXPert Nail 04.013.548SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982088031), received between Oct 18, 2021 and Oct 18, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033618); they may or may not involve this specific model.

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.

• MalfunctionOct 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHILE INSERTING A RAFN NAIL, THE SURGEON WAS HAVING DIFFICULTIES DRILLING THE NAIL. IT WAS DETERMINED THAT THE NAIL WAS NOT PROPERLY CONNECTED. THE GUIDE WAS CORRECTLY ALIGNED AND RECONNECT HANDLE. NO FRAGMENTS WERE GENERATED. THERE WERE 10 MINUTES SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - DRILL: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK - NAIL INSERTION HANDLES (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 11 TI CANN RETRO/ANTEGRADE FEM NL/340-S. THIS REPORT IS 1 OF 1 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12648315 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.