EXPert Nail 04.013.544SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982088024), received between Apr 26, 2021 and Apr 26, 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.

• MalfunctionApr 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 WHILE DRILLING FOR THE DISTAL SCREW OF A RETROGRADE/ANTEGRADE FEMORAL NAIL, THROUGH THE SPIRAL BLADE ATTACHMENT, THE DRILL BIT AND SCREW BOTH SKIVED POSTERIORLY MISSING THE NAIL ALL TOGETHER. THE SCREW WAS ABORTED AND THE SPIRAL BLADE WAS COMPLETED WITHOUT INCIDENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. THIS REPORT IS FOR 1 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/320MM-STERILE THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726989 ↗

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.