Infinity KRR090 (UDI 20845854083526)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20845854083526), received between Jun 12, 2023 and Aug 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.

• MalfunctionAug 28, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, KRR090, INFINITY RETRO-REAMER, 9MM, WAS BEING USED DURING AN ACL PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿DURING THE SURGERY, WHILE DRILLING, THE TIP OF THE REAMER BROKE AND THE BROKEN PIECE WAS FOUND INSIDE THE KNEE JOINT, WHICH WAS IDENTIFIED USING C-ARM AND REMOVED. THE PATIENT'S CONDITION IS GOOD.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE SAME DEVICE WHICH CAUSED A 20-MINUTE 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 20084551 ↗
• MalfunctionJun 12, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE KRR090, INFINITY RETRO-REAMER, 9MM, WAS BEING USED DURING AN ACL RECONSTRUCTION PROCEDURE ON 31JAN23 WHEN IT WAS REPORTED, ¿THE CUTTING TIP IS BROKEN.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. FURTHER ASSESSMENT QUESTIONS FOUND THAT THE DEVICE BROKE, AND A FRAGMENT FELL INTO PATIENT. FRAGMENT WAS REMOVED USING A GRASPER OR KELLY STRAIGHT CLAMP. THE PROCEDURE WAS COMPLETED WITH A 10-DELAY USING AN ALTERNATE DEVICE. 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 17105214 ↗