EXPert Nail 04.004.352SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982083951), received between Dec 20, 2017 and Feb 5, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Disassembly” (1 report).

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 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.

• InjuryFeb 5, 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 PATIENT RETURNED TO SURGERY FOR AN EXCHANGE TIBIAL RODDING THE DIAGNOSIS WAS A NONUNION TIBIAL SHAFT FRACTURE, STATUS POST TIBIAL RODDING. DATE OF INITIAL RODDING WAS UNKNOWN. THE SYNTHES TIBIAL NAIL AND 4 SCREWS WERE REMOVED WITH NO COMPLICATIONS. EVERYTHING WAS REMOVED COMPLETELY, AND NOTHING WAS BROKEN. THE MEDULLARY CANAL WAS REAMED AND A NEW TIBIAL NAIL WAS INSERTED. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THERE ARE NO X-RAYS AVAILABLE. CONCOMITANT DEVICES REPORTED: SCREWS: TRAUMA ( PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 4). THIS REPORT INVOLVES ONE (1) 9MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11285186 ↗
• MalfunctionDec 20, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO REMOVE THE CONNECTING SCREW FROM THE TIBIAL NAIL WITH USE OF THE INSERTION HANDLE. THE ENTIRE NAIL HAD TO BE REMOVED FROM THE PATIENT AND A NEW NAIL INSERTED WITH ANOTHER INSTRUMENT SET. THERE WAS A SURGICAL DELAY OF 15 MINUTES. THE IM (INTRAMEDULLARY) ROD - TIBIAL FRACTURE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: INSERTION HANDLE ((B)(4), LOT # 1485664, QUANTITY OF 1). THIS COMPLAINT INVOLVES TWO DEVICES. THIS REPORT IS FOR A TIBIAL NAIL. (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7133546 ↗

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.