Infinity AIM™ KSC20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854649913), received between Nov 29, 2022 and Nov 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2022Peeled/Delaminated; Peeled/Delaminated

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, KSC20, INFINITY AIM SUTURE CUTTER AND SKID WAS BEING USED ON (B)(6) 2022 DURING A KNEE ARTHROSCOPY, MENISCAL REPAIR PROCEDURE AND THE ¿SKID PEELED OFF PLASTIC DURING THE CASE INSIDE THE PATIENT. PLASTIC WAS REMOVED.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE AND THERE WAS NO DELAY TO THE PROCEDURE. AFTER FURTHER ASSESSMENT IT WAS DISCOVERED THAT "THE NEEDLE RIDES DOWN THE SLED INTO THE JOINT PROTECTING THE CARTILAGE. WHEN THIS WAS DONE THE NEEDLE DROVE INTO THE "PLASTIC" OR WHATEVER MATERIAL IT IS AND SHRED IT OFF. " THE SHAVER AND SUCTION WERE USED TO RETRIEVE THE FRAGMENTS. THE PATIENT IS "DOING GREAT". 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 15876821 ↗