POWERPRO PRO2033Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854028384), received between Jul 29, 2024 and Jul 29, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO2033, POWERPRO HIGH SPEED DRILL ATTACHMENT WAS BEING USED ON (B)(6) 2024 DURING A PODIATRY CASE AND ¿A HIGH SPEED DRILL ATTACHMENT BROKE APART DURING A CASE TODAY. MULTIPLE PIECES LANDED IN THE PATIENT¿. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT OR USER. PER FURTHER ASSESSMENT IT WAS FOUND THAT THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE HIGH SPEED DRILL ATTACHMENT AND A DELAY OF A HALF HOUR TO AN HOUR. THE PATIENT IS "RECOVERING AND THERE WAS NO EXTENDED HOSPITALIZATION". THE PRO8500SB, HALL MICROFREE MINI-DRIVER WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE WAS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19849494 ↗