Infinity KRR100 (UDI 20845854083540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20845854083540), received between Jan 11, 2023 and Jun 11, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, KRR100, INFINITY RETRO-REAMER, 10 MM, WAS BEING USED DURING AN ACL REPAIR PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿WHEN THE SURGEON STARTED TO DRILL TIBIAL TUNNEL RETROREAMER 10MM BROKE INTO THE BONE. THE DISTAL TIP OF THE REAMER BROKE IN TWO PARTS. SURGEON FINALLY GET ALL THE PARTS.¿. ALTHOUGH THE DEVICE DID FRAGMENT, ALL FRAGMENTATION OF THIS DEVICE WAS RETRIEVED FROM THE PATIENT. AN ALTERNATE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE CAUSING A DELAY OF 20-MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 22182820 ↗
• InjuryJun 11, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, KRR100, INFINITY RETRO-REAMER, 10 MM, WAS BEING USED DURING AN ACL REPAIR PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿WHEN THE SURGEON STARTED TO DRILL TIBIAL TUNNEL RETROREAMER 10MM BROKE INTO THE BONE. THE DISTAL TIP OF THE REAMER BROKE IN TWO PARTS. SURGEON DIDN¿T GET ALL THE PARTS AND ONE PART WAS IMPOSSIBLE TO RECOVER. HE DID ALL THE TRICKS TO DO IT BUT IT WAS NOT POSSIBLE. NOT SURE IF THE PIECE IS INTO THE PATIENT OR REMOVED DURING THE EXPLORATION.¿. AN ALTERNATE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE CAUSING A DELAY OF 20-MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE FRAGMENTATION LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22182779 ↗
• MalfunctionJun 16, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE KRR100, INFINITY RETRO-REAMER, 10MM, WAS BEING USED DURING A RECONSTRUCTION ACL ALLINSIDE PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿THE CUTTING TIP IS BROKEN.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿THE TIP WAS RECOVERED. IT CAME OUT STILL ATTACHED TO THE DRILL BIT.¿. THE PROCEDURE WAS COMPLETED WITH A 10-MINUTE DELAY AND THE USE OF AN ALTERNATE RETRO DRILL DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿UNKNOWN, NO NEWS REPORTED.¿. 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 17146027 ↗
• MalfunctionJan 11, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KRR100, INFINITY RETRO-REAMER, 10MM, LOT NUMBER 1247658 X2, WAS BEING USED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿WHILE RETRO REAMING THE TIBIAL SOCKET, THE TIPS OF 3X KRR100'S BROKE¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 10-MINUTE DELAY. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE WAS BROKEN IN THE PATIENT AND THE FRAGMENTATION OF ALL DEVICES WERE REMOVED WITH A GRASPER. SURGEON SUSPECTS IT KEPT BREAKING ON THE TIBIAL SPINE. 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 16136660 ↗