EXPert Nail 04.034.234SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982094933), received between May 11, 2018 and Jan 26, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING INTRA-OP PATIENT REQUESTED TO HAVE BIL EX TIBIA NAILS, AND SCREWS, REMOVED DUE TO PAIN AND IRRITATION. THE IMPLANTS ON THE RIGHT SIDE WERE REMOVED WITHOUT INCIDENT. THE IMPLANTS ON THE LEFT WERE DIFFICULT. THE END CAP WAS REMOVED, AND NAIL EXTRACTOR THREADED INTO NAIL. THE DISTAL SCREW WAS REMOVED. WHILE ATTEMPTING TO REMOVE PROXIMAL SCREW, THE SCREW HEAD BROKE OFF OF THE SHAFT, AND LOOKED TO BE COLD WELDED INTO THE HEAD OF THE SCREW. THE BROKEN SCREW REMOVAL SET WAS OPENED AND SURGEON ATTEMPTED TO GET SCREW SHAFT OUT OF NAIL/TIBIA. THE BROKEN SCREW REMOVAL INSTRUMENTS WERE UNABLE TO ASSIST IN REMOVING THE SCREW SHAFT. THE SURGEON HAD TO OPEN SKIN MEDIALLY, AND USE AN OSTEOTOME TO CUT BONE AWAY FROM SCREW ON LATERAL AND MEDIAL SIDES. HE WAS THEN ABLE TO TAMP THE SCREW SHAFT OUT OF PATIENT. HE THEN PROCEEDED TO REMOVE THE NAIL. THERE WAS SURGICAL DELAY OF SIXTY (60) MINUTES. ACTION WAS TAKEN OF OPENED ADDITIONAL SETS/INSTRUMENTS, X-RAY WERE TAKEN AND THERE WERE FRAGMENTS GENERATED AND THE FRAGMENTS WERE REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCES ARE UNKNOWN. THIS COMPLAINT IN

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 16247151 ↗
• MalfunctionMay 11, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, THE SURGEON COULD NOT DISENGAGE THE CANNULATED CONNECTING SCREW FROM THE IMPLANTED TITANIUM CANNULATED TIBIAL NAIL. SURGEON WAS ABLE TO USE A SCREWDRIVER AND OPEN END WRENCH TO REMOVE THE CONNECTING SCREW. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THIS COMPLAINT IS FOR A 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 270MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7508552 ↗

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.