NA 03.010.017Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982066954), received between Mar 27, 2019 and Feb 24, 2025 — classified as 3 malfunctions.

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

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 16, 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.

• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT DURING EXAMINATION, THE TIP OF THE INSERTION HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446141 ↗
• MalfunctionSep 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE DOING A TIBIAL NAIL PROCEDURE, THE TIBIAL NAIL WAS DOING FINE BUT UPON EXTRACTING THE INSERTION HANDLE IT WAS FOUND TO BE ALMOST COLD-WELDED. THE INSERTION HANDLE WAS STUCK FOR TEN (10) MINUTES BEFORE IT BECAME UNLOCKED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-EX INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10491014 ↗
• MalfunctionMar 27, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THERE WAS AN AIMING ARM JIG FOR THE TIBIAL NAIL EXPERT THAT WAS NOT WORKING PROPERLY. THE UNKNOWN TIBIAL NAIL IMPLANT WAS FINE, BUT THE AIMING ARM FOR TITANIUM CANNULATED NAIL-EXPERT AND TIBIAL NAIL-EXPERT INSERTION HANDLE WAS BENT. THE TROCARS DID NOT LINE UP PROPERLY WITH THE NEW TIBIAL NAIL IMPLANT. THE OBLIQUE SCREWS WERE BEING PUT INTO THE TIBIAL NAIL THROUGH THE AIMING ARM AND THE TROCAR WOULD NOT PROPERLY LINE UP. THE SCREWS WERE NOT GOING THROUGH THE TIBIAL NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN TIBIAL NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1); UNKNOWN OBLIQUE SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) TIBIAL NAIL-EX INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455377 ↗