EXPert Nail 04.013.864SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982088581), received between Aug 27, 2019 and Feb 18, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF ONE (1) TI CANNULATED ANTEGRADE FEMORAL NAIL AND THREE (3) LOCKING SCREW ON (B)(6) 2021, DUE TO NONUNION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11343097 ↗
• InjuryAug 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO NONUNION. THE PATIENT HAD MALUNION DISTAL FEMUR WITH MODIFIED EXPERT RETROGRADE ANTEROGRADE FEMORAL NAIL (EX RAFN). THE PATIENT WAS IMPLANTED WITH THE FOLLOWING DEVICES; ONE (1) EX RAFN NAIL, TWO (2) UNKNOWN 6.0MM SCREW, ONE (1) UNKNOWN 5.0MM SCREW, ONE (1) UNKNOWN SPIRAL BLADE, ONE (1) UNKNOWN END CAP ON (B)(6) 2018. THE EX RAFN WAS MODIFIED BY THE SURGEON FROM THE PREVIOUS PROCEDURE BY DRILLING 5.0MM HOLE INTO THE SHAFT OF NAIL FOR A 5.0MM SCREW FOR A BONE TRANSPORT PROCEDURE. THE REAMER IRRIGATION ASPIRATOR (RIA) WAS USED TO HARVEST BONE GRAFT. IT WAS REVISED TO A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) CONDYLAR PLATE WITH ARTICULATING TENSION DEVICE AND 3.5/4.5MM LCP METAPHYSEAL PLATE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 14MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/420MM-STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 8934649 ↗

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.