EXPert Nail 04.013.344SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982087683), received between May 27, 2019 and Jan 9, 2024 — 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.

• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY FOR REMOVAL OF HARDWARE DUE TO NON-UNION AFTER TREATMENT WITH RAFN (RETROGRADE/ANTEGRADE FEMORAL NAIL). REVISION NAILING WAS PERFORMED. INITIAL IMPLANT DATE FOR THE NAIL IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 9MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/320MM-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18475119 ↗
• InjuryMay 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) AND HARDWARE REMOVAL DUE TO IMPLANTS NEED TO COME OUT FOR STAGING AND CONVERTED TO THE TOTAL HIP PROCEDURE. THE FOLLOWING DEVICES WERE INITIALLY IMPLANTED ON AN UNKNOWN DATE; ONE (1) RETROGRADE FEMORAL NAIL, ONE (1) 5.0MM/60MM TITANIUM LOCKING SCREW, ONE (1) 5.0MM/28MM TITANIUM LOCKING SCREW, UNKNOWN DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) PLATE, AND ONE (1) DHS/DCS LAG SCREW. NOTHING WAS BROKEN AND THERE WAS NO ISSUE ON THE DEVICES REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 9MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/320MM-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8644058 ↗

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.