EXPert Nail 04.013.756SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982088390), received between May 29, 2019 and Apr 16, 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.

• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A RETROGRADE NAIL EXCHANGE WAS DONE BECAUSE OF A POSSIBLE INFECTION AND NONUNION. THE ORIGINAL INJURY WAS DONE DUE TO A GUNSHOT TO THE DISTAL FEMUR. THE NAIL AND HARDWARE WERE SUCCESSFULLY EXCHANGED. THERE WAS ONE (1) 5.0MM BROKEN SCREW PROXIMALLY THAT WAS SUCCESSFULLY REMOVED. WHILE INSERTING THE NEW NAIL, THE SURGEON HIT THE NAIL WITH THE SECOND MOST DISTAL SCREW DRILL BIT. HOWEVER, ADJUSTMENTS WERE MADE AND THE SURGEON WAS ABLE TO PLACE THE SCREW SUCCESSFULLY. THE SURGEON WAS LEANING ON THE AIMING ARM CAUSING IT TO BEND AND MISS THE NAIL. THERE WAS A TWENTY (20) MINUTES SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS GOOD. THIS REPORT CAPTURES THE POST-OP EVENT OF POSSIBLE INFECTION AND NONUNION WHILE RELATED COMPLAINT (B)(4) CAPTURES THE INTRA-OP EVENT DURING INSERTION OF THE NEW NAIL THE SURGEON HIT THE NAIL WITH THE SECOND MOST DISTAL SCREW DRILL BIT. THIS REPORT IS FOR ONE (1) 13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Post Operative Wound Infection

  MAUDE report 11682367 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF A RETROGRADE NAIL DUE TO POSSIBLE INFECTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS GOOD. THIS REPORT IS FOR A RETROGRADE NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8650147 ↗

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.