Y-Knot YRC02Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20845854080549), received between Oct 11, 2017 and Feb 4, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, YRC02, RC ALL-SUTURE ANCHOR, WITH HI-FI SUTURES WAS BEING USED ON (B)(6) 2026, THE HOSPITAL NEWLY PURCHASED THE YRC02 Y-KNOT ALL-SUTURE ANCHOR. DURING THE SHOULDER JOINT SURGERY, THE FRONT END OF THE ANCHOR BROKE WHEN THE ANCHOR BODY WAS INSERTED, CAUSING THE FRONT END OF THE WIRE TO FALL OFF AND MAKING THE ANCHOR UNUSABLE.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. PER FURTHER ASSESSMENT IT WAS REPORTED THAT WHAT WAS MEANT BY THE "WIRE" WAS THE INSERTER. THE INSERTER FRAGMENTED AND FELL INTO THE SURGICAL SITE AND WAS RETRIEVED." 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 24258867 ↗
• MalfunctionJul 9, 2025Material Fragmentation; Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE YRC02, RC ALL-SUTURE ANCHOR,WITH HI-FI SUTURES DEVICE WAS USED IN A SHOULDER JOINT PROCEDURE ON (B)(6) 2025, AND ¿DURING THE SHOULDER JOINT SURGERY, WHEN THE SCREW WAS BEING INSERTED, THE FRONT END OF THE INSTRUMENT BROKE, CAUSING THE THREAD BUNDLE TO FALL OFF AND BECOME UNUSABLE.THE SURGERY WAS COMPLETED BY REPLACING IT WITH A NEW DEVICE.¿. FURTHER ASSESSMENT FOUND THAT ¿THE FRONT END OF THE INSTRUMENT¿ REFERRED TO ¿TIP OF THE INSERTER¿, AND THE TERM ¿BROKE¿ MEANT ¿CRACKED¿. THE CUSTOMER ALSO INDICATED THAT THE DEVICE FRAGMENTED AND FELL INTO THE SURGICAL SITE. ALL FRAGMENTS WERE RETRIEVED WITH FORCEPS. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT, AND THE PATIENT'S CURRENT STATUS IS "RECOVERED". 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 22456666 ↗
• InjuryFeb 14, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE YRC02, RC ALL-SUTURE ANCHOR, WITH HI-FI SUTURES LOT NUMBER 1412500 WAS BEING USED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. WHEN IT WAS REPORTED ¿DURING THE PROCEDURE, TWO YRC02 PRODUCTS WERE USED: ONE WAS ATTEMPTED WITHOUT THE USE OF AN OWL BY SELF-PUNCHING, AND THE OTHER WAS ATTEMPTED WITH THE USE OF AN OWL FOR HOLE FORMATION FOLLOWED BY ANCHOR INSERTION. IN BOTH CASES, ONE TIP OF THE SHAFT BROKE. THE REMOVED TIP WAS IDENTIFIED AND REMOVED USING A GRASPER FOR ONE OF THE PRODUCTS, BUT THE OTHER TIP FROM THE ANOTHER PRODUCT WAS FOUND TO BE STUCK IN THE CORTICAL BONE AND COULD NOT BE REMOVED. SUBSEQUENTLY, THE PATIENT'S X-RAY WAS TAKEN, AND THERE WERE NO ABNORMALITIES FOUND IN THE PATIENT'S CONDITION.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT RETAINING A FOREIGN BODY AND DUE TO IT IS NOT POSSIBLE TO KNOWN WHICH LOT NUMBER THIS FAILURE OCCURRED WITH.

  Patient problems: Foreign Body In Patient

  MAUDE report 21383710 ↗
• InjuryFeb 14, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE YRC02, RC ALL-SUTURE ANCHOR,WITH HI-FI SUTURES LOT NUMBER 1404463 WAS BEING USED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2025 WHEN IT WAS REPORTED ¿DURING THE PROCEDURE, TWO YRC02 PRODUCTS WERE USED: ONE WAS ATTEMPTED WITHOUT THE USE OF AN OWL BY SELF-PUNCHING, AND THE OTHER WAS ATTEMPTED WITH THE USE OF AN OWL FOR HOLE FORMATION FOLLOWED BY ANCHOR INSERTION. IN BOTH CASES, ONE TIP OF THE SHAFT BROKE. THE REMOVED TIP WAS IDENTIFIED AND REMOVED USING A GRASPER FOR ONE OF THE PRODUCTS, BUT THE OTHER TIP FROM THE ANOTHER PRODUCT WAS FOUND TO BE STUCK IN THE CORTICAL BONE AND COULD NOT BE REMOVED. SUBSEQUENTLY, THE PATIENT'S X-RAY WAS TAKEN, AND THERE WERE NO ABNORMALITIES FOUND IN THE PATIENT'S CONDITION.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT RETAINING A FOREIGN BODY AND DUE TO IT IS NOT POSSIBLE TO KNOWN WHICH LOT NUMBER THIS FAILURE OCCURRED WITH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21383709 ↗
• InjuryFeb 8, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE YRC02 Y-KNOT RC ALL-SUTURE ANCHOR, WITH TWO NO. 2 WAS BEING USED ON (B)(6) 2023 DURING A ROTATOR CUFF TEAR SURGERY AND ¿DURING ROTATOR CUFF RECONSTRUCTION, ONE OF THE TWO METAL TIPS OF THE YRC02 SETTING TOOL BROKE OFF¿. FURTHER ASSESSMENT DISCOVERED THAT THE FRAGMENT WAS NOT RETRIEVED, ¿NO, BECAUSE IT STAYED IN SITU. THE DAMAGE FOR THE PATIENT WOULD BE TO BIG, IF THEY HAVE TO REMOVE IT.¿ AT THIS TIME A 2ND SURGERY TO REMOVE THE FRAGMENT HAS NOT BEEN PLANNED. THERE WAS NO MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION REQUIRED FOR THE PATIENT/USER. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE AND THERE WAS NO DELAY. THE PATIENT IS REPORTED AS "NO ISSUES SO FAR". THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO FRAGMENT REMAINING IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16325126 ↗
• InjuryJan 22, 2018Break; Break

  THIS INCIDENT WAS REPORTED TO CONMED ON (B)(4) 2016 AND DEEMED NONREPORTABLE ON 31-OCT-2016. ON 08-JAN-2018, A HISTORICAL COMPLAINT REVIEW WAS PULLED FOR THIS PRODUCT CODE AND THIS INCIDENT WAS REASSESSED. A CUSTOMER REPORTED DURING AN ARTHROSCOPIC SHOULDER SURGERY, AN ANCHOR BROKE AND A TIP WAS LEFT IN THE PILOT HOLE. THE SURGEONS COULD NOT RETRIEVE THIS "TIP" AS THE PATIENT'S BONE WAS HARD. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT INJURY WAS REPORTED. THIS INCIDENT HAS BEEN DEEMED REPORTABLE ON THE BASIS OF A DEVICE MALFUNCTION WHERE A NON-IMPLANTABLE DEVICE COMPONENT REMAINED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7210530 ↗
• MalfunctionOct 11, 2017Delivered as Unsterile Product; Delivered as Unsterile Product

  A STERILITY BREACH WAS REPORTED ON A YRC02 ANCHOR. THIS WAS FOUND DURING INSPECTION; THEREFORE, THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS COLLECTED FROM THE SALES REPRESENTATIVE THAT THE ANCHOR CAME IN A BOX OF 10 AND SEEMED TO HAVE A CREASE IN IT AS IF IT HAD BEEN FOLDED DURING SHIPMENT. THERE WAS NO OBVIOUS BREACH OF STERILITY, HOWEVER, THIS DEVICE WAS DISCARDED AND NOT USED DUE TO UNCERTAINTY. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 6940025 ↗