Y-Knot YRC02STARecalls & reported problems
Conmed Corporation · Y-Knot® RC with Tape, One 2 mm blue Hi-Fi® Tape, one #2 (5 metric) blue/black Hi-Fi Suture · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854044728), received between May 14, 2019 and May 14, 2019 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2019Material Fragmentation; Material Fragmentation
THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE YRC02STA DEVICE WAS BEING USED DURING A TIBIOFIBULAR LIGAMENT REPAIR ON (B)(6) 2019 WHEN THE TIP OF THE INSERTER BROKE OFF IN THE BUR HOLE WHILE BEING INSERTED BY THE SURGEON. THE FRACTURED TIP WAS REMOVED FROM THE PATIENT'S BUR HOLE BY A K-WIRE AND SHARP SPOON. THIS CAUSED AN ~30-MINUTE DELAY IN THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT OR THE USER. THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION REQUIRED. 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 8607423 ↗
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- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
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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