EXPert Nail 04.013.752SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982088383), received between Nov 9, 2020 and Dec 30, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A PROCEDURE. THE SURGEON DECIDED TO USE A RETRO/ANTEGRADE FEMORAL NAIL (RAFN) FOR A PROXIMAL THIRD FEMUR FRACTURE. WHILE INSERTING THE NAIL, THE SURGEON NOTICED A MORE PROXIMAL FRACTURE EXTENDING AROUND THE LESSER TROCHANTER REGION. IT¿S UNCLEAR IF THIS FRACTURE EXISTED BEFORE THE SURGERY. THE SURGEON ULTIMATELY DECIDED TO DRIVE THE NAIL IN FURTHER PROXIMAL AND USED THE LATERAL TO MEDIAL LOCKING SCREW OPTIONS PROXIMALLY ALONG WITH ONE A TOP SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. NO PATIENT CONSEQUENCES NOTED. THIS REPORT IS FOR A RAFN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13119488 ↗
• MalfunctionNov 9, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT FOR A SURGERY. DURING NAIL INSERTION THE NAIL BROKE THE PROXIMAL FEMUR. THERE WERE NO FRAGMENTS ARE GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 13 TI CANN RETRO/ANTEGRADE FEM NL/360-S. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780661 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF RETROGRADE/ANTEGRADE FEMORAL NAIL DUE TO FEMORAL NONUNION. INSERTION OF A NEW RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN), OSTEOTOMY, AND INSERTION OF ANGLED BLADE PLATE WERE DONE. THE REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10813700 ↗

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.