NA 04.005.556Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982086242), received between Nov 20, 2020 and Apr 10, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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

• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT HARDWARE REMOVAL DEEP DUE TO RIGHT FEMUR PAINFUL HARDWARE. THE PLATE SCREWS AND STIMULATOR BODIES WERE REMOVED. THE STIMULATOR ELECTRODES WERE ENCASED IN BONE AND WERE NOT EXTRACTED. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 66 FOR IM NAILS. THIS IS REPORT 4 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16709613 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A CONCERN OVER THE STABILITY OF FX: REMOVAL OF NAIL AND SCREWS. AN IM REAMING OF FEMORAL CANAL WAS COMPLETED. THE SURGEON PUT IN LARGER NAIL / SUPPLEMENT WITH A PROXIMAL FEMUR HOOK PLATE. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 66 FOR IM NAILS. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity

  MAUDE report 15438198 ↗
• MalfunctionAug 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SOUTH KOREA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE SCREWS IN QUESTION COULD NOT BE INSERTED INTO THE BONE DURING DRILLING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 66MM FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312467 ↗
• InjuryNov 20, 2020Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY AROUND 9PM TO REPOSITION THE EXPERT HAN NAIL, EXPERT END CAP, SPIRAL BLADE, AND THREE (3) LOCKING SCREWS. THE ORIGINAL PROCEDURE WAS COMPLETED ON (B)(6) 2020 IN THE AFTERNOON. THE SURGEON ORIGINALLY PLACED THE EXPERT HAN NAIL BUT DIAGNOSTIC IMAGING SHOWED EVIDENCE THAT THE EXPERT HAN NAIL REMAINED EXTRAMEDULLARY IN THE MID-DISTAL THIRD OF THE TIBIA. THIS REQUIRED REVISION SURGERY TO CARRY OUT REPOSITIONING OF THE IMPLANTS. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) LOCKSCR Ø5 L66 F/NAILS TAN LIGHT GREEN. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10876975 ↗