EXPert 03.010.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982066923), received between Jan 26, 2021 and Jul 26, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE FOUND TO HAVE WEAR AND TEAR. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) COMPRESSION DEVICE/ FOR TI CANNULATED TIBIA NAILS-EX. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102778 ↗
• MalfunctionJul 26, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE FOUND TO HAVE WEAR AND TEAR. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) COMPRESSION DEVICE/ FOR TI CANNULATED TIBIA NAILS-EX. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102759 ↗
• MalfunctionJul 26, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE FOUND TO HAVE WEAR AND TEAR. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) COMPRESSION DEVICE/ FOR TI CANNULATED TIBIA NAILS-EX. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102757 ↗
• MalfunctionJul 26, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE FOUND TO HAVE WEAR AND TEAR. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) COMPRESSION DEVICE/ FOR TI CANNULATED TIBIA NAILS-EX. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102754 ↗
• MalfunctionJan 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2021 THAT THE COMPRESSION SCREW WAS USED INCORRECTLY IN A CASE. COMPRESSION SCREW BECAME STUCK INSIDE OF CONNECTING SCREW. THE TWO SCREWS WERE UNABLE TO BE DISCONNECTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO SURGICAL DELAYED REPORTED. THERE WERE FRAGMENTS GENERATED AND THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX (PART NUMBER 03.010.404, LOT UNKNOWN, QUANTITY. THIS REPORT INVOLVES ONE (1) COMPRESSION DEVICE/ FOR TI CANNULATED TIBIA NAILS-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229212 ↗

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.