NA 1806-3540Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04546540196606), received between Mar 20, 2019 and Feb 13, 2026 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Fracture

  AS REPORTED: "THE DRILL BIT BROKE. ALL ITEMS HAVE BEEN REMOVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332518 ↗
• MalfunctionSep 24, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "DURING DRILLING WITH T2 SURGICAL INSTRUMENT DRILL TIP AO TYPE 3.5 DIAMETER, 230M LENGTH, THE DRILL TIP BROKE OFF DUE TO INTERFERENCE WITH THE GUIDE PIN. THE DRILL TIP WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137847 ↗
• MalfunctionSep 23, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "INTRAOPERATIVE ORIF (T2) FOR LEFT HUMERAL DIAPHYSIS FRACTURE. AO DRILL BROKE DURING DRILLING. NO RESIDUE IN THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23128282 ↗
• MalfunctionJun 9, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "BREAKAGE OF 3.5 MM DRILL. BREAKAGE OCCURRED WHEN THE AFFECTED LEG WAS ROTATED INTERNALLY AND EXTERNALLY TO CONFIRM THE DIRECTION OF THE DISTAL TRANSVERSE STOP DRILL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166438 ↗
• MalfunctionMar 10, 2025Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  THE DRILL TIP INTERFERED WITH THE NAIL WHEN DRILLING FOR THE DISTAL LOCKING SCREW INSERTION, AND THE DRILL BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562453 ↗
• InjuryFeb 14, 2025Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  AS REPORTED: "DURING T2H SURGERY, SCREWS WERE INSERTED TO THE DISTAL HOLES OF THE NAIL AND THE FRACTURE WAS CRIMPED WITH A BACK STRIKE. THE DRILL THEN DID NOT PASS THROUGH THE OBLIQUE HOLE OF THE NAIL DURING FIXATION OF THE PROXIMAL HOLES. AFTER CHANGING TO SCREW INSERTION INTO THE TRANSVERSE HOLES, THE DRILL DID NOT PASS THROUGH, SO THE CONNECTION BETWEEN THE DEVICE AND THE NAIL WAS RETIGHTENED WITH A WRENCH, BUT THE SITUATION DID NOT CHANGE. THE SCREW HOLE WAS WIDENED IN ORDER STARTING WITH THE THINNER K-WIRE AND FINALLY THE DRILL WAS PASSED INTO THE HOLE, THE TIP OF THE DRILL BROKE OFF IN THE HOLE, AND IT WAS LEFT IN PLACE. FURTHERMORE, THE DEVICE CONNECTIONS OF THE NAIL WAS OBSERVED TO EXTEND OUTWARD OVER THE ENTIRE CIRCUMFERENCE. FINALLY, ONE SCREW WAS INSERTED IN THE PROXIMAL OBLIQUE HOLE, AND THE SURGERY WAS COMPLETED BY TIGHTENING THE END CAP".

  Patient problems: Foreign Body In Patient

  MAUDE report 21390096 ↗
• InjuryJan 27, 2025Break; Fracture; Break; Fracture

  DURING SHOULDER NAIL IMPLANTATION SURGERY WHILE DRILLING REUSABLE DRILL BROKE AND PART OF IT REMAIN IN THE BONE AS IT WAS NOT POSSIBLE TO REMOVE IT. PART OF THE DRILL REMAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21246728 ↗
• InjuryJan 27, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING SHOULDER NAIL IMPLANTATION REUSABLE DRILL BROKE WHILE DRILLING. DEBRIS WERE RETRIEVED COMPLETELY FROM PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246132 ↗
• MalfunctionDec 16, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED, THE DRILL INTERFERED WITH THE NAIL BEFORE SCREW INSERTION, RESULTING IN BREAKAGE OF THE DRILL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20947588 ↗
• MalfunctionNov 15, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DRILL BREAK OFF". NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698904 ↗
• MalfunctionNov 13, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DRILL BREAK OFF". NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679410 ↗
• MalfunctionApr 4, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DURING DRILLING, THE DRILL BROKE OFF UNDER LOAD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040072 ↗
• MalfunctionFeb 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED: WHILE DRILLING, THE DRILL BIT BROKE. ADDITIONALLY, IT WAS REPORTED, ALL THE DEBRIS WERE REMOVED FROM THE SURGICAL FIELD/PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727688 ↗
• MalfunctionNov 30, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "ORIF WAS PERFORMED FOR RIGHT HUMERAL SHAFT FRACTURE ON NOVEMBER 8, 2023. WHEN DRILLING INTO THE HOLE OF THE NAIL, THE DRILL CONTACTED WITH THE NAIL AND ADVANCED WITHOUT GETTING INTO THE HOLE OF THE NAIL, RESULTING IN FRACTURE OF THE DRILL TIP. THE DRILL TIP WAS STUCK IN THE BONE, BUT WAS REMOVED BY GRASPING IT WITH PLIERS. THE DOCTOR TOLD THAT UNINTENDED CONTACT OF THE DRILL WITH THE K-WIRE JUST BEFORE THE DRILL WAS INSERTED INTO THE NAIL HOLE MIGHT AFFECT THE REPORTED FRACTURE OF THE DRILL TIP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18240012 ↗
• MalfunctionOct 30, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DURING T2H SURGERY, A DRILL BROKE WHILE DRILLING IN THE OBLIQUE DIRECTION IN A PROXIMAL DYNAMIC HOLE. THE OTHER DRILL ALSO BROKE. NO BROKEN FRAGMENTS REMAINED IN THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035821 ↗
• MalfunctionOct 30, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DURING T2H SURGERY, A DRILL BROKE WHILE DRILLING IN THE OBLIQUE DIRECTION IN A PROXIMAL DYNAMIC HOLE. THE OTHER DRILL ALSO BROKE. NO BROKEN FRAGMENTS REMAINED IN THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035820 ↗
• InjuryAug 23, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DURING T2 PROXIMAL HUMERUS NAIL SURGERY THE DRILL BROKE OFF. THE DRILL WAS BROKEN DURING DRILLING AT PROXIMAL A/P LOCKING HOLE. THE BROKEN DRILL TIP WAS REMOVED BY OPENING A NEW SMALL WOUND." ADDITIONALLY IT WAS REPORTED THAT THERE WAS A 30 MINUTE SURGICAL DELAY.

  Patient problems: Perforation

  MAUDE report 17602279 ↗
• MalfunctionOct 19, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DURING THE DRILLING TO THE PROXIMAL HOLES OF T2PH NAIL, THE DRILL BROKE OFF. THERE IS NO DEBRIS IN THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15631800 ↗
• InjuryMay 20, 2021Break; Break

  IT WAS REPORTED THE DRILL BROKE DURING SURGERY; THE BROKEN BIT WAS FULLY RETRIEVED FROM THE PATIENT. THERE WAS A 30 MINUTE DELAY IN SURGERY, WHICH DID NOT REQUIRE ADDITIONAL ANESTHESIA. AN INCISION OPPOSITE FROM AND IN ADDITION TO THE NAIL SIDE WAS MADE IN ORDER TO REMOVE THE BROKEN BIT. THE PROCEDURE WAS COMPETED SUCCESSFULLY WITH A BACKUP DEVICE.

  Patient problems: Laceration(s)

  MAUDE report 11854860 ↗
• MalfunctionJul 1, 2020Fracture; Fracture

  AS REPORTED: "T2 HUMERUS, RIGHT, ORIF. AT THE TIME OF DISTAL LATERAL FIXATION, IT WAS OPENED WITH A RADIOLUCENT DRILL AND MEASURED WITH A DEPTH GAUGE, BUT IT DID NOT REACH THE CORTICAL BONE ON THE OTHER SIDE. WHEN RE-DRILLING, THE USUAL DRILL (1806-3540) WAS USED, BUT IT WAS BROKEN AFTER PENETRATING THE CORTICAL BONE ON THE OPPOSITE SIDE. THE BROKEN DRILL TIP WAS ABOUT 5 TO 10 MM FROM THE CORTICAL BONE ON THE FRONT SIDE, AND COULD BE REMOVED WITH PLIERS. AFTER THAT, THE USUAL PROCEDURE WAS PERFORMED AND THE OPERATION WAS COMPLETED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10218481 ↗
• MalfunctionMar 20, 2019Break; Fracture; Fracture

  DAMAGE TO THE DRILL OCCURRED. THE OPERATION WAS COMPLETED SUCCESSFULLY, AND THE DAMAGE WAS CONFIRMED AFTER WASHING THE INSTRUMENTS POST-OPERATIVELY. NO INTRA-OPERATIVE INSTRUMENT DAMAGE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8438094 ↗