NA 1896-4040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540202406), received between Oct 31, 2018 and Aug 23, 2022 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER SERVICE REPORTED THIS BECAUSE THERE IS THE NOTION OF MATERIOVIGILANCE ON THE ORDER FORM RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 15276829 ↗
• InjuryDec 28, 2021Migration; Migration

  IT WAS REPORTED THAT AFTER SURGERY OF THE T2 HUMERAL NAIL, THE MOST PROXIMAL AND MOST DISTAL SCREWS HAVE BACKED OUT. REVISION SURGERY IS PLANNED AT (B)(6) 2021. UPDATE 12/17/2021: REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 13102142 ↗
• InjuryJun 25, 2021Fracture; Fracture

  A PATIENT WHO HAD AN OPERATION AT THE (B)(6) MEDICAL CENTER LAST YEAR WAS DISCHARGED FROM THE HOSPITAL AND THEN RE-FRACTURED AND WAS ADMITTED TO THE (B)(6) HOSPITAL. TWO OF THE THREE T2GTN DISTAL SCREWS BROKE. THE DOCTOR DIAGNOSED NONUNION AND PERFORMED REVISION SURGERY.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12068849 ↗
• MalfunctionOct 31, 2018Break; Failure to Advance

  IT WAS REPORTED THAT WHEN THE SCREW (1896-4040S) WAS INSERTED WITH SCREW DRIVER, THE HEAD WAS STRIPPED AND THE SCREW WAS NOT ABLE TO BE ADVANCED. THEREFORE, THE NEW SAME SCREW WAS INSERTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8026440 ↗