NA 1806-3545Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540196620), received between Oct 25, 2019 and Jun 7, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "T2PHL WAS USED IN AN ORIF FOR A PROXIMAL HUMERUS FRACTURE. TWO DRILLS WERE BROKEN WHEN DRILLING INTO THE PROXIMAL SCREW HOLE USING THE TARGET DEVICE. THE TIPS OF THE DRILLS WERE REMOVED USING PLIERS AND WAS NOT RETAINED IN THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628589 ↗
• MalfunctionJun 7, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "T2PHL WAS USED IN AN ORIF FOR A PROXIMAL HUMERUS FRACTURE. TWO DRILLS WERE BROKEN WHEN DRILLING INTO THE PROXIMAL SCREW HOLE USING THE TARGET DEVICE. THE TIPS OF THE DRILLS WERE REMOVED USING PLIERS AND WAS NOT RETAINED IN THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628585 ↗
• MalfunctionDec 16, 2021Break; Fracture; Break; Fracture

  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." ON 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 13023236 ↗
• MalfunctionJun 25, 2021Break; Break

  IT WAS REPORTED THAT DURING THE PROXIMAL DRILL, THE SURGEON FORGOT THAT THE GUIDE ROD WAS INSERTED IN THE NAIL, AND THE TIP OF THE DRILL WAS DAMAGED. THE DAMAGED PART WAS LEFT ATTACHED TO THE NAIL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12069626 ↗
• MalfunctionMar 22, 2021Break; Break

  AS REPORTED; "THE DRILL (18063545) BROKE DURING PROXIMAL DRILLING OF THE T2 HUMERUS NAIL. THE BROKEN DRILL WAS REMOVED AND THERE WAS NO RESIDUAL INSIDE THE BODY. THE PROCEDURE COMPLETED WITHOUT PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548325 ↗
• MalfunctionJan 13, 2021Break; Break

  AS REPORTED: "THE EVENT OCCURRED DURING THE INITIAL SURGERY FOR HUMERUS. THE TIP OF THE DRILL BROKE WHEN DRILLING OF THE PROXIMAL DEVICE. THE TIP REMAINED IN THE BODY FOR A WHILE, BUT IT WAS REMOVED ALL AND THE OPERATION WAS COMPLETED USING THE OTHER DRILL TIP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167991 ↗
• MalfunctionNov 19, 2019Fracture; Fracture

  DURING THE UPPER ARM OPERATION, WHEN THE PROXIMAL DRILL WHOLE WAS ATTEMPTED TO CREATE, THE TIP PART OF THE DRILL WAS BROKEN. THE BROKEN PIECE WAS LEFT INSIDE THE BODY ONCE, BUT IT WAS ABLE TO TAKE OUT SAFELY USING A DEVICE. THE PROCEDURE COMPLETED SUCCESSFULLY USING THE REPLACED DRILL. THE SURGEON¿S OPINION: THE PATIENT¿S BONE QUALITY WAS SO HARD THAT IT COULDN¿T BE HELPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9345722 ↗
• MalfunctionOct 25, 2019Break; Fracture; Fracture

  AFTER INSERTING THE NAIL, THE DISTAL PART WAS FIXED WITH THREE SCREWS. THE DRILL TIP BROKE WHEN DRILLING THE SECOND PROXIMAL SCREW HOLE. BECAUSE IT DID NOT BREAK IN THE BONE, THE BROKEN DRILL TIP COULD BE RECOVERED WITH PLIERS. USING ANOTHER DRILL, DRILLING TO A DIFFERENT LOCATION, THE PROCEDURE WAS FINISHED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9242128 ↗