Y-KNOT Y1802ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20845854041793), received between Oct 24, 2017 and Sep 12, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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.

• MalfunctionSep 12, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE Y1802A, Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR LOT NUMBER 1309633 WAS BEING USED DURING A BTB PROCEDURE ON (B)(6) 2023 DATE WHEN IT WAS REPORTED ¿1.3 MM YKNOT FLEX & 1.8MM YKNOT FLEX EACH ONE GOT DAMAGED WHILE PERFORMING A SURGERY.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED WITH THE USE OF AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THE Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR LOT NUMBER 1238822 WILL BE LISTED AS A CONCOMITANT DEVICE. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728247 ↗
• MalfunctionMay 25, 2021Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE Y1802A DEVICE WAS BEING USED ON (B)(6) 2021 DURING AN ANTERIOR TALOFIBULAR LIGAMENT PROCEDURE WHEN IT WAS REPORTED THAT " PILOT HOLE WAS CREATED IN THE LEFT FIBULA. THEN, Y-KNOT 1.8 SUTURE ANCHOR WAS INSERTED USING A MALLET. HOWEVER, Y-KNOT 1.8 SUTURE ANCHOR COULD NOT BE INSERTED INTO THE PILOT HOLE. Y-KNOT 1.8 SUTURE ANCHOR WAS INSERTED OUTSIDE OF THE PILOT HOLE AND ONE OF THE TIPS OF THE INSERTER BROKE. AFTER THIS INCIDENT OCCURRED, THE BROKEN PIECE WAS SEARCHED. X RAY IMAGE (INCLUDING LIVE IMAGE) WAS ALSO USED TO FIND IT. HOWEVER, IT COULD NOT BE FOUND. AFTER THAT, IT WAS FOUND ON THE FLOOR OF THE OPERATION ROOM. THE SURGERY WAS COMPLETED. Y-KNOT 1.8 SUTURE ANCHOR WAS INSERTED OUTSIDE OF THE PILOT HOLE. ACCORDING TO THE SURGEON, THE REASON OF THE BREAKAGE OF THE INSERTER IS A TECHNICAL ERROR. AS Y-KNOT 1.8 SUTURE ANCHOR WAS INSERTED WITH A MALLET, THE TIP OF THE DRILL GUIDE SLIPPED". THERE WAS NO REPORT OF INJURY/IMPACT TO THE PATIENT. THERE WAS A DELAY OF ABOUT 20 MINUTES AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND A Y1802. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11875558 ↗
• MalfunctionAug 18, 2020Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, Y1802A, WAS BEING USED DURING A LIGAMENT RECONSTRUCTION ATFL REPAIR WHEN THE STAINLESS-STEEL TIP OF THE INSTRUMENT WAS BROKEN WITH THE ANCHOR WAS INSERTED INTO THE BONE. THE ANCHOR WAS REMOVED, AND THE TIP WAS REMOVED. THERE WAS NO DELAY TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WAS NO IMPACT TO THE PATIENT OR THE USER. THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION REPORTED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10419576 ↗
• MalfunctionMar 30, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED ON 29JAN2018 THAT DURING A BANKART PROCEDURE THE ANCHOR WAS PULLED OUT WITH THE Y1802A, Y-KNOT FLEX 1.8 MM ALL-SUTURE ANCHOR WITH TWO #2 (5 METRIC) HI-FI SUTURES (1 WHITE/BLACK AND 1 BLUE), DRIVER. THIS PROCEDURE TOOK PLACE ON (B)(6) 2017. AFTER THE DEVICE WAS RETURNED THE EVALUATION FOUND THAT THE TIP OF THE DRIVER WAS BROKEN AND THE BROKEN FRAGMENT HAD NOT BEEN RETURNED WITH THE DRIVER. UPON NOTIFICATION A REQUEST TO THE USER FACILITY, VIA THE COUNTRY CONTACT, FOUND THAT THE DRIVER HAD BEEN BROKEN DURING THE PROCEDURE AND THE FRAGMENT WAS RETRIEVED FROM THE SURGICAL SITE USING A GRASPER DEVICE. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH A POTENTIAL FOR INJURY WITH REOCCURRENCE SINCE THE DRIVER TIP BROKE IN THE SURGICAL SITE AND HAD TO BE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7385758 ↗
• MalfunctionOct 24, 2017Packaging Problem; Packaging Problem

  THE DISTRIBUTOR IN (B)(4) REJECTED TWO Y-KNOT FLEX DEVICES WITH "CUTTER MARKS ON STERILE PACKAGE". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 6973342 ↗