PowerPro PRO2041Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854013052), received between Oct 11, 2023 and May 28, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, PRO2041, 1/4 INCH 6.5MM POWERPRO 1/4 INCH CHUCK ATTACHMENT, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿IT WAS REPORTED THAT THIS PRODUCT BROKE INTO TWO PIECES DURING USE.¿ THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONS FOUND THAT THE DEVICE WAS BROKEN DURING SURGERY, FELL INTO THE PATIENT AND WAS RETRIEVED USING FORCEPS. 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 19403632 ↗
• MalfunctionOct 11, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, PRO2041, 1/4 INCH 6.5MM POWERPRO 1/4 INCH CHUCK ATTACHMENT, WAS BEING USED DURING AN EX FIX REMOVAL PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿DR. WAS REMOVING AN X FIT AND CHUCKED UP A STEINMAN PIN AND THE JACOB¿S CHUCK COMPLETELY FELL APART. HE DID NOT PUT MUCH TORQUE AND WAS ABLE TO REMOVE IT WITH HIS HAND AFTERWARDS.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿THERE WAS NO PHYSICAL HARM TO THE PATIENT AT ALL. THE PATIENT IS DOING WELL". THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911197 ↗