POWERPRO PRO2043Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10845854028407), received between May 16, 2022 and Apr 28, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE PRO2043, POWERPRO SAGITTAL SAW ATTACHMENT DEVICE WAS USED IN A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2026, AND ¿IT WAS REPORTED THAT WHEN THE BLADE (5023-136) IS ATTACHED TO THIS ATTACHMENT AND OPERATED, THE BLADE DETACHES.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF UNKNOWN ALTERNATE ¿BACKUP POWER INSTRUMENTS¿. FURTHER ASSESSMENT FOUND THE DEVICE FELL INTO THE PATIENT AND WAS RETRIEVED. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018508 ↗
• MalfunctionNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DEVICE, PRO2043, POWERPRO SAGITTAL SAW ATTACHMENT, WAS BEING USED DURING A LATERJET PROCEDURE ON 01NOV23 AND "THE POWERPRO SAGITTAL SAW ATTACHMENT WAS BEING USED WITH A 90 DEGREE SAW BLADE. WHEN APPLYING FORCE THE CUT, THE BLADE CAME LOOSE AND SHOT OUT OF THE HUB NEARLY HITTING A STAFF MEMBER¿. THE PROCEDURE WAS COMPLETED USING A PRO8250SB, AND THERE WAS A DELAY OF TEN MINUTES. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR USER. A GOOD FAITH EFFORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION; NO RESPONSE WAS RECEIVED. 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 18226804 ↗
• MalfunctionMay 16, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO2043, POWERPRO SAGITTAL SAW ATTACHMENT, WAS USED DURING A TROCHLEAPLASTIC PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿DURING SURGERY THE SAWBLADE BECAME LOOSE FROM THE ATTACHMENT AND FELL TO THE FLOOR. THE OPERATING ROOM STAFF PUT ON A NEW SAWBLADE AND THAT¿S WHEN ON OF THE STAFF REALIZED THAT A SMALL PIECE OF LOCKING SPIKE WAS IN THE WOUND OF THE PATIENT. IT WAS REMOVED OF COURSE. A HALL50 SAW WAS USED, PROBABLY A LOANER DUE TO SERVICE. ACCORDING TO OPERATING ROOM STAFF IT HAS HAPPENED BEFORE, THAT THE SAWBLADE BECOMES LOOSE, BUT NOT TO THE EXTENT THAT THE SAW ATTACHMENT BRAKES.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE REPORTER STATED THAT THE PROCEDURE WAS PROLONGED, WHICH COULD CAUSE INFECTION, WHILE OBTAINING ANOTHER DEVICE; HOWEVER, THE AMOUNT OF TIME IS NOT KNOWN, AND THERE WAS NO REPORT OF THE PATIENT BEING DIAGNOSED WITH INFECTION. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE PRO2043 DEVICE. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE COMPONENT WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE CUSTOMER ALSO ADVISED THAT THEY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14406330 ↗