Y-Knot, Hi-Fi YP1301BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20845854649012), received between Apr 3, 2025 and Mar 5, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE YP1301B, Y-KNOT PRO FLEX 1.3 MM ANCHOR, NO. 2 HI-FI BLUE DEVICE WAS USED IN AN ARTHROSCOPIC SHOULDER LABRAL ARTHROPLASTY PROCEDURE ON (B)(6) 2026, AND ¿DURING BANKART REPAIR, AFTER DRILLING INTO THE GLENOID, THE ANCHOR WAS INSERTED, BUT THE TIP OF THE ANCHOR DID NOT FIT FIRMLY INTO THE BONE HOLE, OR THE BONE QUALITY WAS TOO GOOD AND HARD, SO IT DID NOT ADVANCE AT ALL, AND THE TIP OF THE INSERTER BENT AND BROKE. WE MANAGED TO REMOVE THE BROKEN PART FROM THE BODY USING A GRASPER. AFTER THAT, THE BONE HOLE WAS RE-DRILLED, THE ANCHOR WAS RE-INSERTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE OPERATION TIME DUE TO THIS BREAKAGE WAS EXTENDED BY 5 TO 10 MINUTES.¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521941 ↗
• InjuryJan 12, 2026Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE YP1301B, Y-KNOT PRO FLEX 1.3 MM ANCHOR, NO. 2 HI-FI BLUE DEVICE WAS USED IN AN ABR PROCEDURE ON (B)(6) 2025, AND "ONE SIDE OF THE U-SHAPED PORTION OF THE SHAFT AT THE TIP OF THE ANCHOR BROKE. THE BONE WAS NOT PARTICULARLY HARD, BUT IT WAS A LITTLE TOUGH WHEN TRYING TO REMOVE THE SHAFT. WHEN THE SHAFT WAS LATER REMOVED, IT WAS SLIGHTLY BENT AND THE TIP WAS BROKEN". THE PROCEDURE WAS COMPLETED WITH THE USE OF AN UNKNOWN ALTERNATE DEVICE. FURTHER ASSESSMENT FOUND "IN ORDER TO REMOVE THE FRAGMENTS FROM THE PATIENT, THE ENTIRE ANCHOR HAD TO BE REMOVED, AND CONSIDERING THE RISK TO THE PATIENT, IT WAS LEFT IN PLACE". IT WAS FURTHER CLARIFIED THAT "BOTH THE ANCHOR AND A FRAGMENT [OF THE DRIVER] WERE LEFT IN THE PATIENT". THERE WAS NO MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A RETAINED FRAGMENT OF THE DEVICE DRIVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 24035502 ↗
• InjuryApr 3, 2025Material Fragmentation; Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE YP1301B, Y-KNOT PRO FLEX 1.3 MM ANCHOR, NO. 2 HI-FI BLUE DEVICE WAS USED IN A SHOULDER ARTHROSCOPY / INSTABILITY / BANKART PROCEDURE ON 26MAR25, AND ¿AN INSERTER TOOTH REMAINED IN THE BONE AFTER IMPACTION OF THE YP1301B ANCHOR.¿. FURTHER ASSESSMENT FOUND IT WAS "IMPOSSIBLE TO RETRIEVE" THE FRAGMENT. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND NO DELAY. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF RETAINED FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21761142 ↗