Y-KNOT YRC02N (UDI 20845854045159)Recalls & reported problems
Conmed Corporation · Y-Knot RC with Needles All-Suture Anchor, with Two #2 (5 metric) Hi-Fi Sutures · Class 2 · Implant
All models of Y-KNOT (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854045159), received between Oct 14, 2024 and Oct 14, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2024Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, YRC02N, RC WITH NEEDLES ALL-SUTURE ANCHOR, WITH HI-FI SUTURES, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 24 WHEN IT WAS REPORTED, ¿I HAD A (DEVICE) THAT HAD A METAL TINE BREAK OFF THE IMPLANT DRIVER. THE PIECE WAS LEFT IN BONE. (LT) CAUSED ABOUT 10MIN DELAY. THE FRAGMENT WAS CONFIRMED VIA X-RAY TO BE IN BONE AND WAS LEFT IN PATIENT. IT WAS DETERMINE IT WOULD CAUSE MORE DAMAGE TO REMOVE IT.". THERE WAS NO REPORT OF 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 INJURY OF COMPONENT LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 20438206 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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