T2 1806-0163Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540196095), received between Oct 26, 2018 and Feb 9, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionFeb 9, 2026Break; Fracture

  AS REPORTED: "BREAKING OF THE LOCKING PINS ON A DIAPHYSEAL HUMERAL NAIL." ADDITIONAL FEEDBACK RECEIVED: "HOW WAS THE EVENT DETECTED? DURING SURGERY, WHEN IT BECAME IMPOSSIBLE TO CONTINUE THE PROCEDURE. WHEN INSERTING THE HUMERAL NAIL, THE NAIL WAS PLACED ON THE NAIL HOLDER, THE SCREW WAS TIGHTENED CORRECTLY, AND THE NAIL ANCHOR WAS CHECKED. THE ANVIL WAS POSITIONED TO IMPACT THE NAIL. A ROTATIONAL MOVEMENT WAS PERFORMED TO ALIGN THE NAIL AND POSITION IT CORRECTLY. DURING THE ROTATION, A CRACK WAS HEARD, WITH ABNORMAL MOBILITY BETWEEN THE NAIL HOLDER AND THE NAIL. DID THE EVENT OCCUR DURING THE PROCEDURE? IF YES: WAS THE PROCEDURE COMPLETED CORRECTLY? YES, DURING THE PROCEDURE, IT WAS COMPLETED CORRECTLY. WAS THERE ANY IMPACT ON THE PATIENT?/ANY CLINICAL CONSEQUENCES FOR THE PATIENT? NO IMPACT ON THE PATIENT. WAS THE PROCEDURE DELAYED? IF YES: BY HOW MUCH TIME (IN MINUTES)? THE PROCEDURE WAS DELAYED BY 25-30 MINUTES WHILE WE FETCHED AN ANCILLARY DEVICE TO EXTRACT THE NAIL AND REPOSITION ANOTHER ONE. WAS ADDITIONAL MEDICAL INTERVENTION NECESSARY? NO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300025 ↗
• MalfunctionDec 18, 2019Material Fragmentation; Material Fragmentation

  AS REPORTED: "STAFF WAS TRYING TO AFFIX THE T2 HUMERAL NAIL TO TARGETER WITH NAIL HOLDING BOLT. BOLT WOULD NOT THREAD INTO NAIL. UPON INSPECTION WE NOTICED THREADS ON THE NAIL HOLDING BOLT ARE BROKEN.". ADDITIONALLY REPORTED: EVENT OCCURRED INTRA-OPERATIVELY. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9488556 ↗
• InjuryOct 26, 2018Break; Connection Problem

  IT WAS REPORTED THAT THE NAIL WAS NOT CONNECTED TO TARGET DEVICE WITH T HANDLE. AFTER THAT, THE TARGET DEVICE (1806-0143) AND HOLDING SCREW (1806-0163) WAS LOCKED AND BOTH DEVICES WERE NOT ABLE TO BE REMOVED. THEREFORE, THE TARGET DEVICE WAS NOT USED AND SAME NAIL WAS IMPLANTED AND THE FOUR SCREWS WERE INSERTED WITH FREE HAND TECHNIC. WHEN THE DISTAL SCREW WAS INSERTED, THE BLOOD VESSEL DAMAGED AT THE DISTAL PART OF THE NAIL AND THE VASCULAR SUTURED. CARDIC ARREST OCCURRED DUE TO VASCULAR INJURY, BUT PERFORMED CARDIOPULMONARY RESUSCITATION, PATIENT'S RESUSCITATED. PATIENT DID NOT HAVE RESIDUAL EFFECT. THE DOCTOR REQUESTED THAT CAUSE TARGET DEVICE AND HOLDING SCREW LOCKED AND TROUBLESHOOTING.

  Patient problems: Cardiac Arrest

  MAUDE report 8010619 ↗