EXPert Nail 04.013.552SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982088048), received between Mar 13, 2020 and Aug 29, 2023 — 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.

• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A NONUNION OF PROXIMAL FEMUR. FEMORAL NAILING WAS PERFORMED. PATIENT EXPERIENCE ADVERSE EVENT. REVISION SURGERY WAS REQUIRED. THIS REPORT IS FOR AN 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17643253 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PATIENT SUSTAINED A SECOND INJURY REQUIRING A HEMIARTHROPLASTY. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH A RETROGRADE NAIL. THE NAIL WAS REMOVED AND REPLACED WITH A CURVED CONDYLAR PLATE THAT WOULD ALLOW FOR THE HIP IMPLANT STEM TO FIT INTO THE CANAL. THE NAIL DID NOT FAIL NOR DID IT CAUSE THE SECOND INJURY, IT WAS ONLY REMOVED AND REPLACED WITH A PLATE TO FIX HIS SECOND INJURY. THE PROCEDURE AND THE PATIENT'S STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/ 360MM-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9830847 ↗

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.