PowerPro PRO6232Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10845854036235), received between Oct 6, 2023 and May 7, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO6232, POWERPRO SMALL 2-TRIGGER PIN DRIVER WAS BEING USED ON (B)(6) 2024 AND THE ¿¿PIN DRIVERS FALL APART INTO THE PATIENT TODAY ¿ THE PIN DRIVERS FELL APART AND THERE IS NO WAY TO FIX THEM.¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT 2 DEVICES BROKE IN THIS SURGERY AND "THE INSIDE COMPONENT THAT HOLDS THE PIN IN THE PIN DRIVER FELL OUT". THE COMPONENTS WERE RETRIEVED FROM THE SURGICAL SITE.¿. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. 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 19258720 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO6232, POWERPRO SMALL 2-TRIGGER PIN DRIVER WAS BEING USED ON (B)(6) 2024 AND THE ¿¿PIN DRIVERS FALL APART INTO THE PATIENT TODAY ¿ THE PIN DRIVERS FELL APART AND THERE IS NO WAY TO FIX THEM.¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT 2 DEVICES BROKE IN THIS SURGERY AND "THE INSIDE COMPONENT THAT HOLDS THE PIN IN THE PIN DRIVER FELL OUT". THE COMPONENTS WERE RETRIEVED FROM THE SURGICAL SITE.¿. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. 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 19258680 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  UPDATE: PER INFORMATION RECEIVED ON 5JUN24, THE PINS USED WITH THE PRO6232 "WAS A SMITH & NEPHEW TOTAL SHOULDER PIN (74013490 23KSM0767) I BELIEVE IT IS SAID TO BE 3.2MM (1.25"). IT WORKED IN THEIR OLD PRO6232, BUT THOSE HAD TO BE LIKE 10 YEARS OLD AND MAYBE WORE OUT ENOUGH TO FIT THAT PIN. I ALSO GOT A DIAMETER SIZING CHART AND THAT PIN DID NOT FIT INTO THE 1.25 HOLE. I THINK THE PIN IS A SMIDGE LARGER THAN WHAT THEY SAID.". THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO6232, POWERPRO SMALL 2-TRIGGER PIN DRIVER WAS BEING USED ON (B)(6) 2024 AND THE "¿PIN DRIVERS FALL APART INTO THE PATIENT TODAY¿THE PIN DRIVERS FELL APART AND THERE IS NO WAY TO FIX THEM." PER FURTHER ASSESSMENT, IT WAS FOUND THAT "THE INSIDE COMPONENT THAT HOLDS THE PIN IN THE PIN DRIVER FELL OUT". THE COMPONENT WAS RETRIEVED FROM THE SURGICAL SITE." THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. 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 19258679 ↗
• MalfunctionJan 16, 2024Corroded; Material Fragmentation; Corroded; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PRO6232 DEVICE WAS BEING USED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024, AND ¿PIECES BROKEN OFF FROM USING 3.2MM PIN¿. FOLLOW-UP ASSESSMENT FOUND THAT ¿THE INNER GRIPPING COMPONENTS¿ OF THE PRO6232 ¿BROKE¿, FELL INTO THE SURGICAL SITE AND WERE RETRIEVED. THE PIN IN USE DURING THE PROCEDURE WAS A ZIMMER/BIOMET 3.2MM PIN. THE SALES REPRESENTATIVE CONFIRMED THAT THE ¿THE PIN DID NOT BREAK¿ AND NO FRAGMENTS REMAIN IN THE PATIENT. THE SURGERY WAS COMPLETED AS NORMAL WITH A DIFFERENT PRO6232 AND A DELAY OF ¿2-3 MINUTES TO GET ANOTHER PIN DRIVER¿. NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITAL STAY WAS REQUIRED, AND THE PATIENT IS "FINE". THIS REPORT IS BEING RAISED ON THE BASIS OF A MALFUNCTION OF FRAGMENTATION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516993 ↗
• MalfunctionOct 6, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO6232, POWERPRO SMALL 2-TRIGGER PIN DRIVER, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿BROKEN INTERNAL COMPONENT FELL OFF - PIECES FELL OUT OF THE FRONT OF THE DRIVER.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE BROKE DURING SURGERY. ONE OF THREE FRAGMENTS FELL INTO SURGICAL SITE. THE SURGEON USED HIS HAND TO REMOVE THE SINGLE FRAGMENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORT OF DELAY. 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 17884715 ↗