Y-Knot, OneStep Y1S1KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854901844), received between Apr 2, 2020 and Apr 2, 2020 — 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 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.

• MalfunctionApr 2, 2020Material Fragmentation; Material Fragmentation

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE Y1S1K, Y-NOT ONE-STEP INSERTER, BROKE DURING A BANKART ARTHROSCOPIC SHOULDER PROCEDURE ON (B)(6) 2020 ON A (B)(6) MALE. THE SURGEON ATTEMPTED TO PULL THE BIT FROM THE GUIDE AND IT WOULD NOT RELEASE. THIS TIME THE ANCHOR WOULD NOT PULL OUT THOUGH. LOOKING FOR A SOLUTION, THE SCRUB TECH GAVE THE DRILL SOME LIGHT TAPS WITH A MALLET, TO TRY AND GET IT TO RELEASE WITH NO RESULT. AFTER PULLING WITH EXTREME FORCE THE DRILL BIT BROKE, AT THE BASE OF THE FLAIR NEAR THE CURVED BIT PORTION, LEAVING ROUGHLY 2CM OF DRILL BIT STICKING OUT OF THE GLENOID ALONG WITH THE ANCHOR. THE REPRESENTATIVE HAD THEM ATTEMPT TO PULL THE TAILS OF THE ANCHOR AND CONTINUE PULLING WITH A GRASPER ON THE BROKEN BIT, WHICH ALLOWED IT TO FINALLY RELEASE. THE BROKEN PIECE WAS REMOVED. THERE WAS NO REPORTED DELAY. THERE WAS NO REPORTED PATIENT INJURY. THIS REPORT IS BEING RAISED AS DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9915544 ↗