T2 1806-0143Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540196071), received between Sep 14, 2015 and Feb 9, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Break; Device Difficult to Setup or Prepare

  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 24299727 ↗
• MalfunctionJul 8, 2024Break; Crack; Fracture; Break; Crack; Fracture

  'BROKEN TARGET ARM T2 HUMERUS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19696481 ↗
• MalfunctionMay 31, 2024Failure to Align; Failure to Align

  AS REPORTED: "INCORRECT DRILLING DURING PROXIMAL LOCKING T2 HUMERUS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19435229 ↗
• MalfunctionJul 20, 2022Failure to Align; Failure to Align

  AS REPORTED: "CONSULTANT PUT 2 SCREWS IN THE PROXIMAL HOLES THROUGH THE TARGETER, BOTH SCREWS MISSED THE NAIL. BEFORE USING THE TARGETER THE SURGEON USED A MALLET ON THE TARGETER (EVEN THOUGH ADVISED AGAINST), WE REMOVED BOTH SCREWS AND TIGHTENED THE NAIL HOLDING BOLT ON THE TARGETER. BOTH SCREWS THEN WENT THROUGH THE NAIL AND THE TARGETER WORKED PERFECTLY." THE PROCEDURE WAS DELAYED BY 20 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070826 ↗
• MalfunctionDec 16, 2021Failure to Align; Failure to Align

  AS REPORTED: "THE NAIL COULD NOT BE INSERTED WITHOUT STRONG HAMMERING DURING NAIL INSERTION, AND AFTER INSERTION, THE DRILL BROKE DUE TO MISS-TARGETING DURING PROXIMAL DRILLING. SINCE THE DRILL TIP WAS IN THE SCREW HOLE, THE NAIL WAS EXTRACTED AND DEFORMATION WAS OBSERVED IN THE DEVISE CONNECTION OF THE NAIL." 11/30/2021 - ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SPARE NAIL. NO DEBRIS WERE LEFT INTO THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018469 ↗
• MalfunctionMay 7, 2021Failure to Align; Failure to Align

  AS REPORTED: THIS EVENT OCCURRED IN THE OR AS THE SURGEON WAS DRILLING THROUGH THE PROXIMAL TARGETER CONNECTED TO THE HUMERAL NAIL BEFORE INSERTING THE PROXIMAL INTERLOCKS. THE SURGEON NOTICED THE DRILL DID NOT PROGRESS AS IT SHOULD HAVE AND FOUND THAT THE DRILL WAS MISSING THE PROXIMAL INTERLOCKING SCREW HOLES IN THE NAIL. TO CORRECT THIS, THE SURGEON HAD TO HOLD THE PROXIMAL TARGETER UPWARD SLIGHTLY TO HELP GUIDE THE DRILL BIT IN THE CORRECT TRAJECTORY. THE SURGEON WAS ABLE TO CORRECTLY DRILL THROUGH AND ADD THE PROXIMAL INTERLOCKS FOR THE NAIL WITH SOME MANUAL ADJUSTMENTS TO THE TARGETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794405 ↗
• MalfunctionMar 1, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED: "THE DRIVER COULD NOT BE REMOVED FROM THE SLEEVE WHEN THE SCREW WAS INSERTED OVER THE TARGETING DEVICE. REMOVED THE NAIL AND REPLACE IT WITH A DIFFERENT TARGETING DEVICE, AND RESTART THE OPERATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395256 ↗
• InjuryJul 22, 2020Failure to Align; Failure to Align

  THE DOCTOR INDICATED THAT THE "ARCH WAS CROOKED" AND COULD NOT PERFORM THE SURGICAL PROCEDURE CORRECTLY ("THE SCREW WAS LEFT OUT"), WHICH EXTENDED THE TIME OF THE SURGERY. ADDITIONALLY REPORTED BY THE USER FACILITY: "REGARDING THE EVENT THAT HAPPENED. I CHECKED THE INSTRUMENTS AFTERWARDS AND IT IS NOT MISCALIBRATED." ADDITIONALLY REPORTED BY COMPANY REPRESENTATIVE: "ON JUNE 26TH WE HAVE BEEN NOTIFIED BY THE DOCTOR THAT THE PATIENT WAS LEFT WITH A BRACHIAL NERVE DAMAGE. HE SAID THAT THIS OCCURS IN AROUND 30 TO 60% OF PATIENTS WHO SOFT TISSUE IS PULLED, AND THIS IS WHY HE PREFERRED TO USE THE NAIL TO THE PLATE. AS HE WAS NOT ABLE TO BLOCK WELL WITH THE ARCH, THE BONE CRACKED, HE HAD TO OPEN IT AND WHEN TRYING TO PUT CERCLAGE, THE NERVE WAS PULLED MORE THAN NECESSARY AND THE PATIENT WAS LEFT WITH THAT RESULT. THE RECOVERY OF THE PATIENT IS EXPECTED INTO 6 WEEKS TO 6 MONTHS APPROXIMATELY."

  Patient problems: Bone Fracture(s); Fracture, Arm; Injury; Nerve Damage

  MAUDE report 10308255 ↗
• MalfunctionJul 9, 2020Fracture; Fracture

  THE TEETH/PINS ON THE ADAPTER OF THE TARGET UNIT ARE BROKEN OFF. SURGICAL DELAY OF 15MIN. NOT LONGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10253333 ↗
• MalfunctionDec 23, 2019Failure to Align; Failure to Align

  IT WAS REPORTED, AFTER DRILLING THE OBLIQUE HOLE, THE SURGEON COULD NOT INSERT THE DISTAL SCREW INTO SCREW HOLE WELL. AFTER THE SURGEON DRILLED THE HOLE AGAIN AND TRIED TO INSERT THE SCREW SOMETIME, SUCCEEDED TO INSERT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9513701 ↗
• MalfunctionAug 23, 2019Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method; Difficult or Delayed Positioning

  A MISSDRILLING IN PROXIMAL OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8928307 ↗
• InjuryOct 26, 2018Difficult to Remove

  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 DEVICE 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. CARDIAC ARREST OCCURRED DUE TO VASCULAR INJURY, BUT PERFORMED CARDIOPULMONARY RESUSCITATION, PATIENTS RESUSCITATED. PATIENT DID NOT HAVE RESIDUAL EFFECT. THE DOCTOR REQUESTED THAT CAUSE TARGET DEVICE AND HOLDING SCREW LOCKED AND TROUBLE SHOOTING.

  Patient problems: Cardiac Arrest; Perforation of Vessels; Vascular System (Circulation), Impaired

  MAUDE report 8010616 ↗
• MalfunctionSep 14, 2015Device Operates Differently Than Expected

  IT IS REPORTED BY NURSE OF THE HOSPITAL THAT DURING A SURGERY PROCEDURE IT WASN'T POSSIBLE TO LOCK THE SCREWS AS SPECIFIED WITH TARGET DEVICE. THE SURGERY COULD BE COMPLETED BY FREEHAND-TARGETING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5075482 ↗