Y-Knot YP1802Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20845854050689), received between Jan 5, 2026 and Aug 17, 2026 — classified as 3 injuries, 2 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50273395 ↗
• InjuryAug 11, 2026Material Fragmentation

  The distributor reported on behalf of the customer that the device YP1802, Y-KNOT PRO FLEX 1.8 MM ANCHOR, TWO NO. 2 HI-FI was being used and ¿On (b)(6) 2026, Dr. from (b)(6) Hospital in (b)(6) was performing a shoulder joint arthroscopy-based labrum repair surgery and during the process, he discovered that the insertion rod head of the anchor had a missing tooth after the anchor was implanted. The broken tooth remained in the patient's body.¿ There was no impact or injury to the patient or user. This report is being raised due to the reported injury of fragment of the device remains in the patient.

  Patient problems: Foreign Body In Patient

  MAUDE report 50206929 ↗
• InjuryAug 7, 2026Material Fragmentation

  Patient problems: Foreign Body In Patient

  MAUDE report 50176648 ↗
• InjuryJan 26, 2026Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE YP1802, Y-KNOT PRO FLEX 1.8 MM ANCHOR, TWO NO. 2 HI-FI DEVICE WAS USED IN A SURGERY FOR RECURRENT SHOULDER DISLOCATION ON (B)(6) 2026, AND ¿THE NORMAL DRILL BIT WAS IMPLANTED WITH AN OPEN CIRCUIT, AND THE ANGLE WAS NOT DEVIATED. HOWEVER, THE OPENING AT THE HEAD END BROKE.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE AND A DELAY OF ONE HOUR. FURTHER ASSESSMENT FOUND THE DEVICE FRAGMENTED AND FELL INTO THE SURGICAL SITE AND FRAGMENTS WERE NOT RETRIEVED. "THE FRAGMENTS HAVE ALREADY PENETRATED INTO THE BONES AND ARE DIFFICULT TO REMOVE. THE HOSPITAL HAS COMMUNICATED WITH THE PATIENT TO OBTAIN THEIR UNDERSTANDING AND WILL CONDUCT REGULAR FOLLOW-UPS AFTER THE SURGERY.". THE PATIENT WAS HOSPITALIZED AS "A NORMAL POSTOPERATIVE HOSPITAL STAY, NOT BECAUSE OF THE FRACTURE OF THE EQUIPMENT.". THE PATIENT'S STATUS IS DESCRIBED AS "IN CLINICAL COMMUNICATION AND UNDERSTANDING". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF RETAINED FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24176418 ↗
• MalfunctionJan 5, 2026Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, YP1802, Y-KNOT PRO FLEX 1.8 MM ANCHOR, TWO NO. 2 HI-FI, WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE HOSPITAL PURCHASED YP1802 Y-KNOT ALL-SUTURE ANCHOR ON DECEMBER 10, 2025. AFTER UNPACKING, WHEN PREPARING TO ENTER THE BONE TUNNEL, THE FRONT NAIL BODY (IT IS THE INSERTER PART THAT HAS BROKEN) WAS DAMAGED AFTER TAPPING THE HANDLE, RESULTING IN THE INABILITY TO USE THE CONSUMABLE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT WAS REQUESTED, AND IT WAS FOUND THAT THE MEANING OF BROKEN WAS THAT THE INSERTER FRAGMENTED DURING USE ON THE PATIENT. FRAGMENTATION FELL INTO THE PATIENT AND WAS RETRIEVED WITH FORCEPS. 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 23957143 ↗