Y-Knot YP1301RBRecalls & reported problems
Conmed Corporation · Y-Knot® Pro Flex 1.3 mm Anchor, Ribbon Blue · 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 20845854649029), received between Jul 1, 2025 and Jul 1, 2025 — 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.
InjuryJul 1, 2025Material Fragmentation; Material Fragmentation
CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE YP1301RB, Y-KNOT® PRO FLEX 1.3 MM ANCHOR, RIBBON BL WAS BEING USED ON (B)(6) 2025 DURING A LEFT KNEE MCL AND ¿OF THE FIVE YKNOTS USED, IT WAS DISCOVERED THAT THE TIP OF THE INSERTER (ANCHOR CONNECTION PART) HAD BROKEN AFTER INSERTION ON THE SECOND YKNOT. THE INSERTER WAS ALSO DIFFICULT TO REMOVE AFTER INSERTION, AND WHEN THE HANDLE PART WHERE THE SUTURE WAS LOADED WAS REMOVED AND PULLED OUT, THE TIP WAS BENT IN AN L SHAPE. A POST-OPERATIVE X-RAY CONFIRMED THE BROKEN METAL FRAGMENT. IT WAS DECIDED THAT THE PATIENT WOULD BE MONITORED FOR A WHILE AFTER THE SURGERY.¿ FURTHER ASSESSMENT WAS SENT; HOWEVER, NO UPDATES WERE AVAILABLE. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF DEVICE FRAGMENTATION REMAINS IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22371582 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- 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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