InfinityRecalls & reported problems across all models
Conmed Corporation · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 12 models of Infinity by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Feb 25, 2020 and Jun 4, 2026 — classified as 3 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Infinity problems
Device problems
- Material Fragmentation27
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Foreign Body In Patient3
- No Consequences Or Impact To Patient2
Infinity models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Infinity KBL191ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- Infinity KRR100BIT, SURGICAL4 reports
- Infinity KRR100BIT, SURGICAL4 reports
- Infinity KBR191ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- Infinity KRR090BIT, SURGICAL2 reports
- Infinity KRR095BIT, SURGICAL1 report
- Infinity KRR110BIT, SURGICAL1 report
- Infinity KGP035BIT, SURGICAL1 report
- Infinity KFB035Fastener, fixation, nondegradable, soft tissue1 report
- Infinity KFL100Fastener, fixation, nondegradable, soft tissue1 report
- Infinity KRR090BIT, SURGICAL1 report
- Infinity KBR178ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent Infinity adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 2, 2026Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KFB035 INFINITY FEMORAL ADJUSTABLE LOOP BUTTON DEVICE WAS BEING USED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED ¿DURING A SURGICAL PROCEDURE ONE WAS FOUND DAMAGED.¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE FRAGMENTED INTO THE SURGICAL SITE AND WAS REMOVED WITH THE USE OF A GRASPER AND SUTURE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS "GOOD". THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 24482329 ↗MalfunctionSep 24, 2025Material Fragmentation; Material Fragmentation
THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, KRR095, INFINITY RETRO-REAMER, 9.5 MM WAS BEING USED ON (B)(6) 2025 DURING AN ACL RECONSTRUCTION AND "DURING OPERATION, THE SURGEON WOULD LIKE TO WITHDRAW THE RETRO REAMER AFTER PREPARING THE TIBIAL TUNNEL BUT THEY FOUND THAT THIS WAS DIFFICULT TO TAKE IT OUT AND FINALLY THE SHAFT OF REAMER WAS BROKEN AND STUCK INSIDE THE TUNNEL.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT "THE REAMER HAD BEEN RETRIEVED FROM THE TUNNEL." THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME 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 23131623 ↗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 ↗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 ↗MalfunctionDec 16, 2024Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE KRR110, INFINITY RETRO-REAMER, 11 MM WAS BEING USED ON APPROXIMATELY (B)(6) 2024 DURING AN ACL ALL INSIDE PROCEDURE WHEN IT WAS REPORTED ¿TWO UNITS RETRO REAMER BROKE DURING DRILLING.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS REMOVED WITH THE USE OF AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿DOING FINE AND DISCHARGED FROM THE HOSPITAL.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 20937608 ↗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 ↗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 ↗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 ↗MalfunctionJan 3, 2024Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE DEVICE, KGP035, 3.5MM SPADE TIP GUIDE PIN, WAS IN USE IN AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2023, AND, ¿WHEN THEY WERE PERFORMING THE FEMORAL TUNEL, THE TIP OF THE KGP035 BROKE IN THE FIRST CORTICAL, LEAVING THE TIP INTO THE JOINT. THE SURGEON HAD TO REMOVE IT, DELAYING THE SURGERY, AND MAKING THE SITUATION A LITTLE STRESSFUL¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE, WITH A REPORTED DELAY OF 15 MINUTES. THERE IS NO REPORT OF MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR 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 18438275 ↗MalfunctionNov 8, 2023Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE KFL100, KPS ADJUSTABLE FREE LOOP WAS BEING USED DURING AN ACL & PCL WITH MENISCUS REPAIR PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿BROKE DURING THE SURGERY TIMING.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. 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 18093083 ↗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 ↗InjuryJul 7, 2023Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE DEVICE, KRR090, INFINITY RETRO-REAMER, 9MM, WAS BEING USED DURING AN ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿WE PROCEEDED TO MAKE THE TIBIAL TUNNEL AND WE INDICATED TO THE DOCTOR HOW HE HAD TO DRILL, WHEN HE STARTED EVERYTHING WAS GOING WELL AND SUDDENLY THE REAMER GOT STUCK AND WE WENT TO SEE WHAT HAD HAPPENED AND IT WAS THAT THE FRONT PART OF THE BROCADE WAS BROKEN SO WE HAD TO OPEN ANOTHER ONE TO BE ABLE TO CONTINUE WITH THE SURGERY. IT IS NOTED THAT IT WAS NOT A BAD BROCADE BY THE DOCTOR, BUT THAT THE WING OF THE BROCADE WAS DETACHED FROM THE BODY.¿. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE POSSIBILITY OF A FOREIGN BODY REMAINING INSIDE OF THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17281245 ↗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 ↗
Other Conmed Corporation products
All Conmed Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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