T2 2353-3907Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327411843), received between Sep 10, 2021 and Nov 24, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Failure to Align; Failure to Align

  AS REPORTED: "WHEN INSERTING THE DISTAL ADVANCE LOCKING SCREW, THE DISTAL TARGETING DEVICE WAS LOOSE, AND THE SCREW WAS DRIVEN IN AT AN INCORRECT ANGLE BEYOND THE ACCEPTABLE INSERTION RANGE. AS A RESULT, THE SCREW BECAME STUCK WITH THE NAIL AND COULD NOT BE REMOVED. ALTHOUGH IT WAS EVENTUALLY EXTRACTED WITH EFFORT, THE PRODUCTS WERE DAMAGED." 11/06/2025 - ADDITIONAL INFORMATION RECEIVED: HOW WAS THE ISSUE SOLVED? LONGER SCREW DRIVER WAS USED AS AN ALTERNATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632949 ↗
• MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "GREY BUTTON FELL OUT OF THE TARGETER, NO LONGER ABLE TO LOCK THE TRIPLE SLEEVE INTO THE TARGETER, UNABLE TO PLACE SCREW IN PREFERRED DISTAL LOCKING HOLE".

  Patient problems: Insufficient Information

  MAUDE report 22288219 ↗
• MalfunctionNov 23, 2024Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  AS REPORTED: "WHEN REMOVING THE DISTAL AND PROXIMAL DEVICES AFTER SURGERY, THEY WERE FIRMLY FIXED AND COULD NOT BE REMOVED MANUALLY, SO DR. TRIED TO REMOVE THEM BY HITTING THEM WITH A HAMMER AND DAMAGED THEM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766494 ↗
• InjuryJul 10, 2024Mechanical Jam; Mechanical Jam

  AS REPORTED: "T2 ALPHA FEMUR RETROGRADE DISTAL TARGETING ATTACHMENT MALFUNCTIONED AND WOULD NOT ATTACH TO NAIL HOLDING JIG UNLESS GREAT FORCE WAS APPLIED. ONCE ATTACHED, WITH GREAT EFFORT, IT COULD NOT BE REMOVED. COULD NOT UTILIZE PROXIMAL TARGETING ATTACHMENT, ALSO HAD TO ACQUIRE VARIOUS ADDITIONAL X-RAY ANGLES TO PROPERLY ASCERTAIN NAIL PLACEMENT, SINCE WE COULD NOT REMOVE DISTAL TARGETING ATTACHMENT. BOTH OF THESE CAUSED A PROLONGED PROCEDURE OF 30 MIN."

  Patient problems: Insufficient Information

  MAUDE report 19710015 ↗
• MalfunctionApr 20, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE PIECE THAT HOLDS THE SLEEVE BROKE OFF AND NOW IT WON'T HOLD THE SLEEVES IN PLACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16778166 ↗
• MalfunctionDec 20, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "WHEN CHECKING THE DRILL PASSAGE BEFORE INSERTING THE NAIL, DISTAL TARGETING DEVICE COULD NOT BE ATTACHED TO THE NAIL ADAPTER. THE LOCKING LEVER ON THE TARGETING DEVICE DID NOT MOVE AT ALL. DUE TO POOR FUNCTION, THE PROCEDURE WAS CHANGED TO THE USE OF A RADIOLUCENT DRILL AND THE SURGERY WAS COMPLETED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014778 ↗
• MalfunctionSep 14, 2021Difficult to Insert; Failure to Align; Difficult to Insert; Failure to Align

  THE END USER REPORTED THEY HAD A COLINEAR CLAMP ON LATERALLY AND WHEN THE TARGETING WING WAS ATTACHED IT DID HIT THAT CLAMP. THEY ALSO REPORTED THAT WITH ANTEGRADE NAILS, SOME ROC HAVE MIS-MATCHED THE PATIENT AND MADE INSERTION DIFFICULT. NO ADVERSE CONSEQUENCES WERE REPORTED TO THE PATIENT AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470746 ↗
• MalfunctionSep 10, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT ONE ADVANCED LOCKER MISSED THE LATERAL OBLIQUE HOLE. THE FIRST DRILL PASS HIT A TINE OF A LARGE WEBER CLAMP POSSIBLY AFFECTING THE TRAJECTORY OF THE SCREW. THE SURGEON USED A REGULAR LOCKER AND INSERTION WENT COMPLETELY NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456415 ↗