NA 1806-3555Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540196668), received between Aug 27, 2018 and Nov 28, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "A DRILL BREAKAGE OCCURRED DURING FREEHAND DRILLING FOR INSERTION OF A DISTAL SCREW. THE BROKEN DRILL TIP WAS DEEMED IMPOSSIBLE TO EXTRACT AND WAS LEFT IN THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 15867998 ↗
• MalfunctionMay 7, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE DRILLING FOR A DISTAL LOCKING SCREW, WITH A FREE-HAND TECHNIQUE, THE DRILL BIT BROKE OFF. ALL THE DEBRIS WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317253 ↗
• MalfunctionNov 15, 2018Break

  IT WAS REPORTED THAT WHEN DRILLING WAS DONE WITH FREE HAND TECHNIQUE DURING SURGERY WITH T2H, THE TIP OF THE DRILL WAS BROKEN AND LEFT IN THE BONE. THEREFORE, DRILLED A HOLE WITH CROWN REAMER FROM THE OTHER SIDE AND THE BROKEN PART WAS REMOVED. THE DOCTOR'S OPINION: WHEN HE DRILLED, HE PUT TOO MUCH ANGLE AND IT WAS BROKEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 8075004 ↗
• MalfunctionAug 27, 2018Break; Difficult to Remove

  IT WAS REPORTED THAT THE 3.5MM DRILL WAS BROKEN DURING DRILLING DISTAL HOLE. THE TIP OF THE DRILL REMAINED IN THE BONE AND IT WAS NOT ABLE TO BE REMOVED. THEREFORE, T2 HUMERUS NAIL WAS FIXED WITH OTHER 2 HOLE AND THE OPERATION WAS FINISHED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7820643 ↗