Y-Knot, OneStep Y1S2RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854902117), received between Apr 2, 2020 and Apr 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryApr 2, 2020Break; Material Fragmentation; Break; Material Fragmentation

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE Y1S2R, YKNOT ONE STEP ANCHORS, QTY 2, WERE USED IN A SUB-PECTORAL TENODESIS ON (B)(6) 2020. THE DOCTOR REPORTED THAT BOTH ANCHORS WERE TAKING A WHILE TO DRILL INTO THE BONE, AND THAT THE DRILL TIP MAY NOT BE SHARP ENOUGH TO GO INTO HARD BONE. BOTH ANCHORS DID NOT DEPLOY. THE SECOND ANCHOR'S DRILL BIT BROKE OFF INTO THE FIRST CORTEX HARD BONE. A FLUOROSCOPIC IMAGE WAS TAKEN TO LOCATE THE DRILL TIP. THE METALLIC PIECE IS WITHIN THE INTRAMEDULLARY CANAL. IT'S STABLE IN BONE AT THIS TIME AND DOESN'T NEED TO BE REMOVED PER THE SURGEON. THE SURGEON COMPLETED THE PROCEDURE USING Q-FIX ANCHOR AFTER BOTH ANCHORS FAILED. THE SURGEON REPORTS THE BONE ROBUSTNESS WAS RATED 9 OUT OF 10. THERE WAS NO DELAY REPORTED AND NO PATIENT INJURY REPORTED. THIS WILL BE REPORT IS BEING RAISED AS PATIENT INJURY DUE TO THE METAL FRAGMENT REMAINING IN THE PATIENT'S BONE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9915657 ↗