Y-KNOT YP1301RWRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20845854649036), received between Nov 19, 2024 and Jan 7, 2026 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, YP1301RW, Y-KNOT PRO FLEX 1.3 MM ANCHOR, RIBBON WHITE/BLACK, WAS BEING USED DURING AN ABR PROCEDURE ON 18DEC25 WHEN IT WAS REPORTED, ¿ONE SIDE OF THE U-SHAPED PART OF THE SHAFT AT THE TIP OF THE ANCHOR BROKE. THE BONE WAS HARD, SO IT WAS NECESSARY TO USE A LITTLE FORCE WHEN INSERTING IT, WHICH IS THOUGHT TO HAVE CAUSED MORE STRESS THAN NECESSARY TO BE PLACED ON THE TIP. THIS HAS BEEN OCCURRING FREQUENTLY IN RECENT CASES OF DISLOCATION, AND USERS ARE CALLING FOR IMPROVEMENTS TO THE TIP STRENGTH.". THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT WAS REQUESTED, AND IT WAS REPORTED THAT THE DEVICE FRAGMENTED IN THE PATIENT AND THE FRAGMENTATION WAS NOT RETRIEVED. THE REPORTER DID NOT EXPLAIN WHY THE FRAGMENTATION WAS NOT RETRIEVED. THERE WAS NO DELAY TO THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FOREIGN BODY LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23988644 ↗
• MalfunctionNov 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE DEVICE, YP1301RW, Y-KNOT PRO FLEX 1.3 MM ANCHOR, RIBBON WHITE/BLACK, WAS BEING USED DURING AN ABR PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿WHEN USING THE THIRD YKNOT, THE TIP OF THE INSERTER BROKE. THERE WAS NO PROBLEM WITH THE USAGE PROCEDURE, AND THE BONE WAS NOT HARD, SO THE CAUSE WAS UNCLEAR. HOWEVER, EVEN WHEN EXAMINING THE TIP OF AN ANCHOR THAT WAS INSERTED NORMALLY WITHOUT BREAKING, THE U-SHAPED PORTION OF THE INSERTER WAS SLIGHTLY EXPANDED AFTER INSERTION, SUGGESTING THAT A SIGNIFICANT AMOUNT OF FORCE WAS APPLIED." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT WAS REQUESTED; HOWEVER, TO DATE CONMED HAS NOT RECEIVED A RESPONSE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569508 ↗
• InjuryAug 18, 2025Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE YP1301RW, Y-KNOT PRO FLEX 1.3 MM ANCHOR WAS BEING USED ON (B)(6) 2025 AND ¿USED IN ABR. WHEN USING THE SECOND YKNOT, THE TIP OF THE INSERTER BROKE (ONE OF THE U-SHAPED PARTS). THERE WAS NO PROBLEM WITH THE USAGE PROCEDURE, BUT THE ASSISTANT EXPERIENCED DIFFICULTY DRILLING JUST BEFORE REACHING THE SPECIFIED DEPTH. THE SAME PROBLEM OCCURRED WHEN INSERTING THE IMPLANT. AFTER HAMMERING THE INSERTER FORCEFULLY, THE TIP WAS FOUND TO BE BROKEN. X-RAYS CONFIRMED THAT THE BROKEN FRAGMENT WAS EMBEDDED IN THE BONE TUNNEL, AND THE PATIENT WAS PLACED UNDER OBSERVATION.¿ THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FRAGMENTATION OF THE DEVICE EMBEDDED IN BONE TUNNEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22825916 ↗
• InjuryNov 19, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, YP1301RW, Y-KNOT PRO FLEX 1.3 MM ANCHOR, RIBBON WHITE/BLACK, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿WHEN USING YP1301RW, THE DOCTOR USED A CURVED GUIDE AND DRILLED AS USUAL. WHEN INSERTING THE ANCHOR THROUGH THE GUIDE, THE DOCTOR FELT THAT IT WAS A LITTLE DIFFICULT TO INSERT IT, BUT WHEN HE INSERTED IT WITH A HAMMER, THE INSERTER TIP WAS DAMAGED. THE ANCHOR WAS ABLE TO BE PLACED IN PLACE WITHOUT FALLING OUT, SO THE SURGERY WAS COMPLETED WITH THE DAMAGED PART OF THE INSERTER STILL IN PLACE IN THE BODY.¿. THE PROCEDURE WAS COMPLETED WITH NO DELAY REPORTED. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF DEVICE COMPONENT LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20723458 ↗