2.5mm Drill MDS111125150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10812269020487), received between Jul 10, 2019 and Aug 27, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2019Fracture; Fracture

  A COPY OF USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED IN THE MAIL FROM THE FDA ON (B)(6) 2019. ACCORDING TO THE REPORT A DRILL BIT BROKE. BROKEN PIECES WERE REMOVED AND IMAGING CONFIRMED NO PIECES WERE LEFT IN THE PATIENT'S WOUND. ON (B)(6) 2019, THE REPORTER WAS CONTACTED VIA PHONE AND IT WAS CONFIRMED THAT ALL PIECES WERE REMOVED AND IMPLANTATION OF THE PROXIMAL HUMERUS PLATING SYSTEM WAS COMPLETED USING THE ADDITIONAL DRILL BIT IN THE SET. NO OTHER REPORTS OF PATIENT IMPACTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936460 ↗
• MalfunctionJul 10, 2019Break

  SCRUB TECH NOTED THE TIP OF THE DRILL BIT WAS BROKEN AFTER USE IN RIGHT SHOULDER. TIP OF DRILL BIT WAS VISUALIZED ON C-ARM IMAGING. DOCTOR REMOVED BOTH BROKEN PIECES FROM FIELD. IMAGING WAS TAKEN AND SURGEON CONFIRMED NO FOREIGN BODY REMAINED IN PATIENT'S WOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8775608 ↗