EXPert Nail 04.004.555SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982084538), received between Apr 6, 2018 and Dec 28, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, WHILE DRILLING, THE SURGEON HIT THE NAIL AND DEVICES (INSERTION HANDLE, CANNULATED SCREW, PROTECTION SLEEVE, DRILL SLEEVE, AIMING ARM FOR SUPRATELLAR, TITANIUM CANNULATED TIBIAL NAIL, AND DRILL BIT) DID NOT LINE UP COMPLETELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078237 ↗
• MalfunctionOct 24, 2018Device-Device Incompatibility; Device-Device Incompatibility

  UPDATE 12/04/2018: ADDING THE CONCOMITANT PART; IT WAS REPORTED THAT THERE WAS A DRILL USED WITH NO ALLEGATIONS. MODIFIED EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A PROCEDURE TO IMPLANT A CANNULATED TIBIAL NAIL ON (B)(6) 2018, WHILE DRILLING FOR THE CANNULATED CONNECTING SCREW ON THE PROXIMAL PORTION OF THE NAIL, SURGEON HAD TO SHAKE THE DRILL SO THE DRILL BIT TO PASS THROUGH THE NAIL. THE AIMING ARM, INSERTION HANDLE, DRILL SLEEVE, AND PROTECTION SLEEVE WERE REPORTED TO HAVE CONTRIBUTED TO THE ALIGNMENT DIFFICULTY. NO DEVICES WERE BROKEN BUT THE NAIL WAS HIT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) . THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001033 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL SURGERY FOR THE INSERTION OF A TIBIAL NAIL. POST-OPERATIVE, PATIENT HAD BONE INFECTION AND NON-UNION. A HARDWARE REMOVAL AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. AN 11 MM TI CANNULATED TIBIAL NAIL AND FOUR (4) 5.0 MM TI LOCKING SCREWS WERE REMOVED SUCCESSFULLY AND ALL INTACT. THE REVISION SURGERY ENTAILED THE INSERTION OF AN ANTIBIOTIC NAIL UNTIL THE BONE INFECTION CLEARS AND WILL EVENTUALLY BE REPLACED WITH ANOTHER TIBIAL NAIL. THERE WERE NO SURGICAL DELAYS, SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 11 MM TI CANNULATED TIBIAL NAIL-EX/375 MM-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7402415 ↗

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.