Infinity KRR090 (UDI 20845854902001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854902001), received between Jul 7, 2023 and Jul 7, 2023 — classified as 1 injury.

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.

• InjuryJul 7, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, KRR090, INFINITY RETRO-REAMER, 9MM, WAS BEING USED DURING AN ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿WE PROCEEDED TO MAKE THE TIBIAL TUNNEL AND WE INDICATED TO THE DOCTOR HOW HE HAD TO DRILL, WHEN HE STARTED EVERYTHING WAS GOING WELL AND SUDDENLY THE REAMER GOT STUCK AND WE WENT TO SEE WHAT HAD HAPPENED AND IT WAS THAT THE FRONT PART OF THE BROCADE WAS BROKEN SO WE HAD TO OPEN ANOTHER ONE TO BE ABLE TO CONTINUE WITH THE SURGERY. IT IS NOTED THAT IT WAS NOT A BAD BROCADE BY THE DOCTOR, BUT THAT THE WING OF THE BROCADE WAS DETACHED FROM THE BODY.¿. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE POSSIBILITY OF A FOREIGN BODY REMAINING INSIDE OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17281245 ↗