NA SD03.010.094Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982258595), received between Dec 1, 2020 and Sep 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT, THE SURGEON WAS INSERTING A TIBIA NAIL ADVANCED AND THE SURGEON EXPERIENCED THE FOLLOWING ISSUES: THE AIMING ARM, RADIOLUCENT WAS WORN DOWN AND TROCARS HAVE TOO MUCH MOVEMENT INSIDE THE DESIGNATED HOLES. THE TROCARS DO NOT FIT SNUG INTO THE AIMING ARM ANY MORE. THE INSERTION HANDLE LONG, RADIOLUCENT WAS GETTING STUCK ON THE NAIL WHEN TRYING TO SEPARATE THE TWO PIECES. THIS HAS BEEN AN ISSUE FOR THE SECOND CASE IN A ROW. THE CONNECTION SCREW NEEDS TO BE REPLACED WITH THE INSERTION HANDLE BECAUSE THE NAIL KEEPS GETTING STUCK WHEN TRYING TO DISCONNECT THE NAIL FROM THE INSERTION HANDLE. THE 8MM HEXAGON T-HANDLE SCREW DRIVER WAS POSSIBLY STRIPPED AND NOT ENGAGING IN CONNECTION SCREW. THE LONG REAM ROD PUSHER (BLUE BALL HANDLE) HAS A WEEK SPOT IN SHAFT, ABOUT TO SNAP IN HALF WHEN PRESSURE IS PUT ON SHAFT WHILE USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084379 ↗
• MalfunctionDec 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE CUTTER FOR TITANIUM ELASTIC NAILS WAS BROKEN, TWO (2) 2.7MM REAMING ROD PUSHER 450MM LONG AND ONE (1) HELICAL BLADE/ SCREW MEASURING DEVICE PIECE WERE BROKEN OFF. WHILE, THE STARDRIVE SCREWDRIVER SHAFT T25 3.5MM HEXAGONAL/ SELF-RETAIN AND CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT HEAD WERE STRIPPED. THERE WAS A SURGICAL DELAY OF A COUPLE OF MINUTES. FRAGMENTS WERE GENERATED AND INSTRUMENTS WERE REMOVED. IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS PATIENT INVOLVEMENT. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928619 ↗
• MalfunctionDec 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE CUTTER FOR TITANIUM ELASTIC NAILS WAS BROKEN, TWO (2) 2.7MM REAMING ROD PUSHER 450MM LONG AND ONE (1) HELICAL BLADE/SCREW MEASURING DEVICE PIECE WERE BROKEN OFF. WHILE, THE STARDRIVE SCREWDRIVER SHAFT T25 3.5MM HEXAGONAL/SELF-RETAIN AND CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT HEAD WERE STRIPPED. THERE WAS A SURGICAL DELAY OF A COUPLE OF MINUTES. FRAGMENTS WERE GENERATED AND INSTRUMENTS WERE REMOVED. IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS PATIENT INVOLVEMENT.THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928604 ↗