Infinity KBR191Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30845854902329), received between Feb 25, 2020 and Dec 16, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionDec 16, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KBR191, INFINITY ANTEROMEDIAL GUIDE RIGHT 9/10 MM WAS BEING USED ON (B)(6) 2024 DURING AN ACL RECONSTRUCTION PROCEDURE WHEN IT WAS REPORTED ¿TIP OF THE INSTRUMENT BROKE OFF.¿. FURTHER ASSESSMENT FOUND THAT THE FRAGMENT WAS REMOVED FROM THE SURGICAL SITE WITH THE USE OF THE SURGEONS¿ FINGERS. THE PROCEDURE WAS COMPLETED WITH THE USE OF A 45-DEGREE AWL. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 20943952 ↗
• MalfunctionMar 23, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, KBR191, INFINITYTM ANTEROMEDIAL GUIDE R 9/10MM WAS BEING USED ON (B)(6) 2022 DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE AND ¿INSTRUMENT BROKE DURING SURGERY¿. THERE WAS NO INJURY TO THE PATIENT OR USER REPORTED. THERE WAS ALSO NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THIS EVENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE INFINITY GUIDE. FURTHER ASSESSMENT FOUND THERE WAS NO DELAY TO THE PROCEDURE AND THE DEVICE BROKE WITH NO CONTACT TO THE PATIENT. THE PATIENT STATUS WAS REPORTED AS HAVING ¿NO ISSUES.¿ 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 13861054 ↗
• InjuryFeb 22, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, KBR191, INFINITYTM ANTEROMEDIAL GUIDE R 9/10MM WAS BEING USED ON (B)(6) 2022 DURING AN ACL WITH BTB PROCEDURE AND ¿THE END OF THE GUIDE BROKE OFF WHILE BEING POSITIONED INTRA-ARTICULARLY ON THE PATIENT'S FEMUR. SURGEON WAS ABLE TO RETRIEVE THE DISTAL PORTION OF THE GUIDE, BUT NOT THE SMALL CONNECTING PIECE, WHICH WAS LATER IDENTIFIED ON X-RAY. SURGEON PLANS TO REOPERATE AT SOME POINT AND RETRIEVE IT.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND THERE WAS A 10 MINUTE DELAY TO THE PROCEDURE. FURTHER ASSESSMENT FOUND THE PATIENT WAS, ¿RECOVERING WELL AND WE HAVEN¿T DONE THE SECOND SURGERY YET.¿. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO FRAGMENT OF DEVICE REMAINING IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13576860 ↗
• MalfunctionFeb 25, 2020Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KBR191 DEVICE WAS BEING USED DURING AN ACL PROCEDURE ON (B)(6) 2020 WHEN THE TIP OF THE DEVICE BROKE AT THE WELDING POINT. THE TIP WAS RETRIEVED FROM THE PATIENT AND AFTER A 25-MINUTE DELAY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT OR THE USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9751855 ↗