T2 1830-0001SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540201133), received between Apr 26, 2019 and Oct 19, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "IN A RETROGRADE CASE, THE TIMING OF COMPRESSION SCREW INSERTION WAS INCORRECT. THE COMPRESSION SCREW WAS INSERTED TO THE FRONT OF THE DYNAMIC HOLE WITH THE NAIL HOLDING SCREW REMOVED FROM THE NAIL. BECAUSE THE DEVICE AND THE NAIL WERE NOT SECURED, THE NAIL MIGRATED DEEPLY, RESULTING IN A FRACTURE WITH A THIRD BONE FRAGMENT WHEN ATTEMPTING TO REATTACH THE DEVICE AND THE NAIL IN THE MEDULLARY CAVITY. THE NAIL DEPTH WAS THEN READJUSTED USING A UNIVERSAL ROD AND PROXIMAL SCREW FIXATION WAS PERFORMED. WHEN COMPRESSION WAS ATTEMPTED WITH THE COMPRESSION SCREW AFTER INSERTION OF THE DISTAL SCREW, THE COMPRESSION SCREW COULD NOT MOVE AND COMPRESSION COULD NOT BE PERFORMED, PROBABLY DUE TO CROSS-THREADING. IN ADDITION, BECAUSE THE COMPRESSION SCREW HAD BLOCKED THE SCREW HOLE, THE PLANNED SCREW COULD NOT BE INSERTED AND ONLY ONE DISTAL SCREW FIXATION WAS NEEDED. AS FOR THE END CAP, IT WAS ALSO IMPLANTED WITH ABOUT 2 MM PROTRUDING FROM THE NAIL END DUE TO POOR PLACEMENT OF THE COMPRESSION SCREW." ADDITIONALLY A 60 MINUTE SURGICAL DELAY WAS REPORTED.

  Patient problems: Limb Fracture

  MAUDE report 17969627 ↗
• MalfunctionApr 26, 2019Device Dislodged or Dislocated

  THE SCREW WAS BACKING OUT OF THE NAIL. NAIL IS STILL IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8556595 ↗