Infinity KRR100 (UDI 20845854902025)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20845854902025), received between May 7, 2022 and Jan 11, 2023 — classified as 4 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.

• MalfunctionJan 11, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KRR100, INFINITY RETRO-REAMER, 10MM, LOT NUMBER 1232757 X1, 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 16136661 ↗
• MalfunctionJul 8, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KRR100, INFINITY RETRO-REAMER, 10MM WAS BEING USED DURING AN ACL RECONSTRUCTION ON (B)(6) 2022 WHEN IT WAS REPORTED THAT THE ¿REAMER TIP SHATTERED INSIDE PATIENT WHEN RETRO REAMING THE FEMORAL SOCKET. THE DOCTOR HAD TO FISH OUT 2 PIECES OF THE TIP FROM INSIDE THE JOINT.¿ THE PROCEDURE WAS COMPLETED WITH REPORT OF A 10-MINUTE DELAY TO THE CASE. FURTHER ASSESSMENT FOUND THE REAMER TIP WAS REMOVED FROM INSIDE THE JOINT USING A GRASPER. THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION WAS REQUIRED FOR THE PATIENT. THE PATIENT IS SAID TO BE OKAY AND UNHARMED. 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 14955694 ↗
• MalfunctionMay 26, 2022Material Fragmentation; Material Fragmentation

  THE SALE REPRESENTATIVE REPORTED THAT THE DEVICE, KRR100, INFINITY RETRO-REAMER, 10MM WAS USED DURING AN UNKNOWN PROCEDURE ON APPROXIMATELY (B)(6) 2022 WHEN IT WAS REPORTED THAT ¿ONCE WE BEGAN TO REAM BACK UP ON THE FEMORAL TUNNEL WE GOT ABOUT HALFWAY UP AND NOTICED A STRANGE SOUND FROM THE REAMER. WE ADVANCED IT BACK INTO THE JOINT AND SAW THAT IT WAS STILL FLIPPED. WE HAD SOME TROUBLE WHEN WE TRIED TO FLIP THE REAMER BACK TO NORMAL, ALMOST LIKE IT WAS STUCK. ONCE WE WERE ABLE TO FLIP IT BACK, WE SAW THAT THE BLADE HAD BEEN DISLODGED AND WAS FREE FLOATING IN THE JOINT. WE WERE ABLE TO RETRIEVE IT WITH A GRASPER CAUSING NO HARM TO THE PATIENT.¿ THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. A GOOD FAITH EFFORT WAS COMPLETED FOR FURTHER ASSESSMENT INFORMATION; HOWEVER, NO RESPONSE WAS RECEIVED FROM THE REPORTER TO DATE. 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 14516164 ↗
• MalfunctionMay 7, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE, KRR100, INFINITY RETRO-REAMER, 10MM WAS BEING USED ON (B)(6) 2022 DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE AND ¿WHILE RETRO-REAMING, THE TIP OF THE REAMER BROKE OFF IN 3 PIECES. PIECES WERE RETRIEVED ALONG WITH THE REAMER AND WILL BE RETURNED TO CONMED. NO PATIENT INJURY, 10 MINUTE DELAY¿. AFTER FURTHER ASSESSMENT IT WAS FOUND BECAUSE THE DEVICE BROKE THE PROCEDURE WAS COMPLETED BY SWITCHING TO A DIFFERENT TECHNIQUE, BUT WERE STILL ABLE TO COMPLETE THE PROCEDURE ARTHROSCOPICALLY. THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. 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 14316906 ↗