EXPert 03.010.485Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982069030), received between Oct 27, 2021 and Dec 19, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) , 2023, THE DRIVING CAP BROKE WHEN IMPACTING THE TIBIAL NAIL. THE FRAGMENT WAS LEFT IN THE JIG. ALSO THE INSERT HANDLE THREADED END HAD BROKEN OFF INTO THE AIM ARM. THE IMPACTOR AND JIG HAD BEEN CONNECTED PROPERLY. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A RADIOLUCENT INSERTION HANDLE FOR EXPERT TIBIA NAILS/23MM THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360584 ↗
• MalfunctionMar 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN OPERATION THE JIG ALIGNED ON THE BACK TABLE. DURING INSERTION AND DRILLING THROUGH THE OBLIQUE HOLES ON THE AIMING ARM, THE DRILL DO NOT ALIGN AND HIT THE NAIL. THE DRILL WAS REMOVED, AND IT WAS NECESSARY TO DRILL THROUGH THE OUTER PROTECTION SLEEVE. THIS REPORT INVOLVES ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT TIBIA NAILS/23MM. THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713915 ↗
• MalfunctionMar 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, WHEN DRILLING THROUGH THE OBLIQUE HOLES ON THE AIMING ARM, THE DRILL DID NOT ALIGN AND HIT THE NAIL. THE SURGEON HAD TO REMOVE THE DRILL SLEEVE AND DRILL THROUGH OUTER PROTECTION SLEEVE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713306 ↗
• MalfunctionOct 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A TIBIA OSTEOSYNTHESIS SURGERY, THERE WAS A MISALIGNMENT OF THE PROXIMAL LOCKING OF AN UNKNOWN EXPERT TIBIAL NAIL WITH THE CONNECTING SCREW. THE INSERTION HANDLE AND AIMING ARM WERE UNABLE TO DISASSEMBLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT TIBIA NAILS/23MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705402 ↗

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.