Infinity KBL191Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30845854902305), received between Sep 1, 2020 and Jun 4, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE KBL191, INFINITY ANTEROMEDIAL GUIDE LEFT 9/10 MM WAS BEING USED ON (B)(6) 2026 DURING AN ACL RECONSTRUCTION AND ¿THE OFFSET GUIDE FROM THE LOANER SET SNAPPED IN HALF TODAY. 'YEAH THE SPADE PART POPPED RIGHT OFF WHILE DRILLING THE PIN' FROM THE SURGEON.¿ PER FURTHER ASSESSMENT IT WAS REPORTED "THE DEVICE BROKE IN THE JOINT WHILE DRILLING THE GUIDE PIN. THE BROKEN PARTS OF THE DEVICE WERE RETRIEVED." THERE WAS NO IMPACT OR INJURY TO 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 25390266 ↗
• MalfunctionOct 25, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KBL191, INFINITY ANTEROMEDIAL GUIDE LEFT 9/10 MM WAS BEING USED ON (B)(6) 2024 DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND ¿TIP OF FEMORAL GUIDE BROKE OFF INSTRUMENT¿. PER FURTHER ASSESSMENT IT WAS FOUND "A FRAGMENT DID FALL INTO SURGICAL SITE. IT WAS RETRIEVED.". THERE WAS NO IMPACT OR INJURY FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE. THERE WAS NO DELAY TO THE PROCEDURE. 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 20535131 ↗
• MalfunctionMar 8, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE KBL191, INFINITYTM ANTEROMEDIAL GUIDE L 9/10MM, WAS BEING USED DURING A LCA RECONSTRUCTION PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿WHEN RETRACTING THE INSTRUMENT FROM THE JOINT (AFTER PERFORMING FEMORAL DRILL WITH KGP035) IT DISASSEMBLED. THE DISTAL PART REMAINED IN ARTICULATION AND WAS REMOVED WITHOUT DIFFICULTY.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE FELL INTO THE PATIENT AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT ANY DELAY. THE DEVICE, KGP035, 3.5MM SPADE TIP GUIDE PIN, WAS USED DURING THE PROCEDURE AS A CONCOMITANT 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 18864960 ↗
• MalfunctionJul 26, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE KBL191, INFINITYTM ANTEROMEDIAL GUIDE L 9/10MM WAS BEING USED DURING AN ACL PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿DR. WAS ABOUT TO DRILL THE 3.5MM SPADE TIP PIN (KGP035) WHILE USING THE 9/10MM FEMORAL OFFSET GUIDE (KBL191). AS HE WENT TO HOOK THE BACK OF THE FEMORAL CONDYLE, THE GUIDE TIP BROKE OFF INSIDE THE PATIENT. DR. WAS ABLE TO RETRIEVE ALL THE BROKEN PIECES AND THE PROCEDURE WAS FINISHED WITHOUT INJURY TO THE PATIENT BY DRILLING THE PIN FREEHAND.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS ALSO A 5-MINUTE DELAY REPORTED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT. 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 17395578 ↗
• MalfunctionApr 28, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE KBL191, INFINITYTM ANTEROMEDIAL GUIDE L 9/10MM, WAS BEING USED DURING A BTB PROCEDURE ON THE APPROXIMATE DATE OF (B)(6) 2023 WHEN IT WAS REPORTED, ¿DR. MITHRA WHILE PERFORMING BTB CASE, THE BELOW MENTIONED PARTICULAR INSTRUMENT HAS BROKEN IN THE MID OF THE SURGERY. THEN WITHOUT THIS INSTRUMENT ONLY, DOCTOR HAS COMPLETED THE SURGERY.¿. AFTER FURTHER ASSESSMENT IT WAS REPORTED, THAT THE DEVICE DID FRAGMENT AND ALL PIECES WERE RETRIEVED WITH GENERAL INSTRUMENTATION. THE PROCEDURE WAS COMPLETED AND THERE WAS A 20 MINUTE DELAY. THERE WAS NO REPORT OF INJURY TO THE PATIENT, PROLONGED HOSPITALIZATION, OR MEDICAL INTERVENTION. THE PATIENT WAS REPORTED AS "FINE". 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 16835147 ↗
• MalfunctionSep 1, 2020Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KBL191 WAS BEING USED DURING A ACL RECONSTRUCTION ON 6AUG20 WHEN THE DEVICE WAS "INSERTED GUIDE PER RECOMMENDATIONS AND THE SHAFT SNAPPED IN HALF. FRAGMENT WAS LODGED IN JOINT BUT EASILY REMOVED WITH GRASPER. DELAY OF 1-MIN TO REMOVE FRAGMENT." THERE WAS NO REPORT OF INJURY TO THE PATIENT. THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION CAUSED BY THE EVENT. THE PATIENT WAS REPORTED AS NOW RECOVERING. 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 10479809 ↗