POWERPRO PRO6100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854013038), received between Jun 6, 2018 and Nov 17, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fail-Safe Design Failure” (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 16, 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.

• InjuryNov 17, 2025Mechanical Jam; Mechanical Jam

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PRO6100, POWERPRO ELECTRIC II MODULAR HANDPIECE DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2025, AND ¿A SENIOR SURGEON ¿ WAS PERFORMING SURGERY WHEN SUDDENLY WHILE DRILLING THE DRILL GOT JAMMED AND THE HANDPIECE WENT IN THE AIR AND WAS ABOUT TO COLLIDE ON SIR¿S FACE WHICH HE TRIED TO MANAGE AND SAVE BUT STILL IT STRUCK HIM IN THE FOREHEAD WHERE HE GOT INJURED. THE SYSTEM BECAME UNSTERILE, AND THE SURGERY WAS DELAYED, AND SIR WAS TAKEN FOR FIRST AID AND X-RAY AS WELL.¿ PER FURTHER ASSESSMENT, "THEREAFTER MRI WAS ALSO DONE. CURRENTLY THE SURGEON IS FINE AND RECOVERING. NO OTHER USER NOR PATIENT WAS INJURED DURING THE INCIDENT.". NO FURTHER DESCRIPTION OF THE INJURY WAS PROVIDED. THE D4000, DRIVE SYSTEM WILL BE LISTED AS A CONCOMITANT DEVICE. THERE ARE NO ALLEGATIONS FILED AGAINST IT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED FOREHEAD INJURY SUSTAINED BY THE SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 23568230 ↗
• InjuryJun 6, 2018Fail-Safe Design Failure; Fail-Safe Design Failure

  THIS DISTRIBUTOR REPORTED THAT THE PRO6100, POWERPRO ELECTRIC II MODULAR HANDPIECE, DEVICE WAS CHANGED TO SAFE MODE FROM RUN MODE. HOWEVER, THE DEVICE ACTIVATED, AND THE NURSE HAD HER THUMB CAUGHT IN THE REVOLUTION OF THE DEVICE. IT IS REPORTED THAT THE NURSE'S THUMB WAS FRACTURED. THE EVENT TOOK PLACE DURING SURGERY; HOWEVER, THE TYPE OF PROCEDURE AND DATE OF PROCEDURE IS NOT KNOWN BY THE REPORTER. FURTHER INFORMATION REGARDING THE INJURY WAS REQUESTED BUT WAS NOT AVAILABLE PER THE REPORTER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Bone Fracture(s); No Consequences Or Impact To Patient

  MAUDE report 7575509 ↗