T2 1806-2035Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540379658), received between Sep 23, 2015 and Apr 9, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Crack; Failure to Align

  AS REPORTED: ¿DURING A T2 PHN SURGERY, THE SURGEON DRILLED ALL PROXIMAL SCREWS INCORRECTLY WHEN USING THE T2 PHN TARGETING DEVICE. THE BONDED CONNECTION BETWEEN THE METALLIC AND CARBON PARTS APPEARS TO BE LOOSE. CRACKS ARE VISIBLY PRESENT AT THE JOINT/INTERFACE. 30 MIN SURGICAL DELAY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835634 ↗
• MalfunctionMay 6, 2024Crack; Crack

  AS REPORTED: "THE NAIL-HOLDER IS CRACKED".

  Patient problems: Insufficient Information

  MAUDE report 19254490 ↗
• MalfunctionApr 2, 2024Failure to Align; Positioning Problem; Failure to Align; Positioning Problem

  THE CUSTOMER REPORTED THAT: "ON A FINAL HUMERUS NAIL INSTALLATION, THE TEAM HAD GREAT DIFFICULTY IN SIGHTING THE RIGHT LATERAL HOLE. THE DRILL BIT WAS A BIT HARD TO TEST AFTER THE NAIL HAD BEEN MOUNTED ON THE HOLDER, BUT ONCE THE NAIL WAS IN PLACE ON THE PATIENT, IT WAS MUCH MORE DIFFICULT TO LOCK IT IN PLACE."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028132 ↗
• MalfunctionFeb 12, 2024Failure to Align; Material Deformation; Insufficient Device Problem Information; Failure to Align; Material Deformation; Insufficient Device Problem Information

  AS REPORTED: "PROBLEMS OCCURRED DURING SURGICAL PROCEDURE DUE TO CARBONIC CENTERING DEVICE"

  Patient problems: Insufficient Information

  MAUDE report 18686738 ↗
• MalfunctionDec 21, 2023Failure to Align; Failure to Align

  AS REPORTED: "DIFFICULTY IN INSERTION OF THE MOST RECENTLY POSITIONED SCREW IN THE T2PH NAIL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370757 ↗
• MalfunctionFeb 17, 2022Failure to Align; Failure to Align

  IT WAS REPORTED A MISSED TARGET WAS DISCOVERED WHEN CHECKING THE TARGET ACCURACY BEFORE NAIL INSERTION. SPARE INSTRUMENTS WERE ARRANGED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552501 ↗
• MalfunctionDec 8, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A PROXIMAL HUMERAL NAIL PROCEDURE ON THE PATIENT'S LEFT SIDE, THE TARGETER WOULD NOT RELEASE THE SOFT TISSUE SLEEVE. THE INCISIONS WERE EXTENDED AND THREE PEOPLE WERE NEEDED TO BACK THE CONSTRUCT OUT ENOUGH TO REMOVE THE TARGETER. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962069 ↗
• MalfunctionAug 4, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE SURGEON TRIED TO DRILL AND INSERT THE SCREW TO THE FOURTH SCREW HOLE FROM THE PROXIMAL SIDE OF T2PH NAIL, BUT THE SCREW ENTERED IN FRONT OF THE NAIL, NOT INTO THE HOLE. THE SURGEON EVENTUALLY GAVE UP INSERTING THE FOURTH SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277649 ↗
• MalfunctionJan 22, 2021Fracture; Fracture

  AS REPORTED: DURING T2PH SURGERY FOR PROXIMAL HUMERUS (LEFT), CRACK OF THE DISTAL END OF THE TARGET DEVICE WAS NOTICED. IT IS UNKNOWN WHETHER THE DEVICE WAS CRACKED BECAUSE IT INTERFERED WITH NAIL DURING DRILLING OF THE NAIL OF THE MOST DISTAL. IT WAS PLANNING TO INSERT TWO DISTAL SCREWS, BUT THE SURGEON INSERTED ONLY ONE AND COMPLETED THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11215931 ↗
• MalfunctionMay 21, 2020Failure to Align; Failure to Align

  AS REPORTED: "MISSDRILLING OCCURED DURING 3 MEDICAL PROCEDURES."

  Patient problems: No Information

  MAUDE report 10080253 ↗
• MalfunctionApr 30, 2020Crack; Failure to Align; Crack; Failure to Align

  IT WAS REPORTED, THE DISTAL LOCKING HOLE OF THE PROXIMAL HUMERAL NAIL TARGETING ARM WAS BROKEN. THIS CAUSED THE DRILL BIT TO MISS THE MOST DISTAL LOCKING HOLE IN THE NAIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10015524 ↗
• MalfunctionAug 6, 2019Improper or Incorrect Procedure or Method

  THE DISTAL LOCKING OF THE SHORT PHN IMPLANTS REPEATEDLY RESULTED IN MISSDRILLING. THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY PERFORMING A FREEHAND LOCKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8867810 ↗
• MalfunctionFeb 5, 2019Misfire

  MISDRILL CAUSED BY TARGET DEVICE OCCURRED. BEFORE INSERTING THE NAIL, AFTER ATTACHING THE NAIL TO THE TARGET DEVICE, CONFIRM THE SAFETY OF THE DEVICE, THE T2PH NAIL WAS INSERTED INTO THE BONE, A MISDRILL OCCURRED WITH A TOTAL OF 4 SCREWS EXCLUDING ONE SCREW IN THE NAIL CENTER PILLAR. WHEN ALL THE SCREWS WERE REMOVED AND THE TARGET DEVICE WAS CONFIRMED AGAIN USING THE DRILL OUTSIDE THE BONE, THE DISTORTION OF THE TARGET DEVICE AND DRILL MARKS WERE CONFIRMED AT A PLURALITY OF LOCATIONS OF THE T2 NAIL. IN A HURRY, WE DIVERTED T2PH NAIL INSTRUMENTS AND IMPLANTS FROM NEARBY FACILITIES AND HANDLED THE OPERATION. ALTHOUGH OPENING A NEW T2PH NAIL AND ATTACHING IT TO THE TARGET DEVICE, SINCE THERE WAS DISTORTION OF THE TARGET DEVICE, AFTER STERILIZING THE INSTRUMENT THAT WAS NEWLY DIVERTED, CHANGING THE TARGET DEVICE ALL THE IMPLANTS WERE INSERTED AND THE OPERATION ENDED. PROLONGED PROCEDURE TIME WAS 2 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8304956 ↗
• MalfunctionSep 23, 2015Device Operates Differently Than Expected

  IT IS REPORTED BY THE SURGEON OF THE HOSPITAL, THAT HE HAD TWO MISDRILLINGS DURING A SURGERY PROCEDURE. HE COMPLETED THE SURGERY BY USING FREEHAND TARGETING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5096886 ↗