EXPert Nail 04.034.358SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982095145), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K040762); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF HARDWARE AND REVISION OF TIBIA INTRAMEDULLARY (IM) NAIL DUE TO NON-UNION. A SCREW WAS ALSO BROKEN PRIOR TO SURGERY ON (B)(6) 2021. ONE FRAGMENT LEFT IN AND RETAINED IN THE PATIENT AND NOT RETRIEVED. IT IS UNKNOWN WHEN THE SCREW BROKE. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2020. THE NAIL AND SCREWS WERE EXPLANTED SUCCESSFULLY. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATION OR SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12571763 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040762. One submission often covers many models, so check the product and lot details in each record.

• Z-2051-2015 · Jun 3, 2015 · Terminated
  TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.