Y-Knot YRC03Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20845854080556), received between Mar 22, 2018 and Oct 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, YRC03, RC ALL-SUTURE ANCHOR WITH HI-FI SUTURES, WAS BEING USED DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿DURING A ROTATOR CUFF REPAIR: AFTER INSERTING THE ANCHOR THE SURGEON NOTICE THAT A TIP OF THE METAL ANCHOR INSERTER IS MISSING. THE SURGEON FINDS THE METAL TIP AND CAN RETRIEVE IT OUT OF THE JOINT." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 10-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 20531656 ↗
• MalfunctionMay 22, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE YRC03, Y-KNOT RC ALL-SUTURE ANCHOR, WITH THREE NO. 2 WAS BEING USED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2024 AND ¿AFTER INSERTING THE ANCHOR, THE OR NURSE NOTICED THAT THE TIP OF THE ANCHOR WAS MISSING. THE ANCHOR DEPLOYED AS NORMAL. AFTER SOME SEARCHING, THEY FOUND THE TIP INSIDE THE JOINT AND WERE ABLE TO GET IT OUT.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. PER FURTHER ASSESSMENT IT WAS FOUND ¿AFTER THE INSERTION OF THE ANCHOR, THEY NOTICED THAT THE TIP OF THE INSERTER WAS MISSING. AFTER THEY DEPLOYED THE ANCHOR, THE METAL PIECE CAME TO NOTICE INSIDE THE JOINT. THEY COULD CATCH IT AND TAKE IT OUT. ¿ THE PROCEDURE WAS COMPLETED WITH A 5 MINUTE DELAY AND WITHOUT THE USE OF AN ALTERNATE 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 19369399 ↗
• MalfunctionMar 22, 2018Detachment Of Device Component; Detachment Of Device Component

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A RC REPAIR, ONE OF THE METAL TIPS OF THE YRC03 DRIVER BROKE OFF AND THE IMPLANT PULLED OUT. THE BROKEN METAL TIP WAS RETRIEVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE YRC03 WITH A 7-MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. UPON GATHERING ADDITIONAL INFORMATION, THE REPORTER STATED THAT NO ADDITIONAL TREATMENT OR HOSPITAL STAY WAS REQUIRED DUE TO THIS INCIDENT AND THE PATIENT WAS RECOVERING AS EXPECTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7363811 ↗