Y-KNOT Y1301Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 20845854021658), received between Sep 19, 2017 and Sep 4, 2026 — classified as 13 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (24 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Conmed Japan reported on behalf of the customer that the Y1301 FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR, was found after post-operative care when a Peroneus superior retinaculum repair (Das-De method) procedure was performed on an unknown date when it was reported, ¿a Y-Knot Flex anchor (1.3 mm diameter, with one No. 2 suture) was inserted into the tibia. It has been approximately seven months since the surgery, yet the patient continues to experience persistent bone pain at the anchor insertion site.¿. Further assessment questioning confirmed that the device did not malfunction during this procedure. The patient had no pathological conditions of bone, no restriction for healing and no foreign body sensitivities. The procedure was completed and it was also reported ¿according to the doctor, they will monitor the situation for about a year and then reassess whether removal is necessary.¿. There was no report of medical intervention, or extended hospitalization for the patient. This report is being raised due to the reported injury due to the patient obtaining post operative pain at the insertion site.

  Patient problems: Implant Pain

  MAUDE report 50614234 ↗
• MalfunctionMar 19, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, Y1301, FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR, WAS USED DURING AN ARCR PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿WE PERFORMED THE DRILLING AND ANCHOR INSERTION AS PER THE STANDARD PROCEDURE. AFTER ANCHORING, WE NOTICED THAT ONE SIDE OF THE BIFURCATED TIP OF THE INSERTER HAD FRACTURED. THE BROKEN FRAGMENT IS PRESUMED TO HAVE REMAINED ON THE FLAT-BLADE PORTION OF THE ANCHOR, OR, IF EXTREMELY SMALL, MAY HAVE BEEN CARRIED OUT OF THE JOINT SPACE WITH THE IRRIGATION FLOW.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT A REPORTED DELAY. FURTHER ASSESSMENT FROM THE REPORTER STATED, ¿THE FRAGMENTATION WAS NOT LEFT IN THE PATIENT¿. 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 24637085 ↗
• MalfunctionDec 18, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, Y1301, FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR, WAS USED DURING AN ARTHROSCOPIC SURGERY, WITH THE IMPLANT SITE BEING THE ANKLE JOINT PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE HOSPITAL NEWLY PURCHASED Y1301 FULL-SUTURE ANCHOR BOLTS. AFTER BEING HAMMERED IN, THE SMALL TEETH AT THE FRONT END BROKE, MAKING THIS CONSUMABLE UNUSABLE.¿. FURTHER ASSESSMENT WAS REQUESTED AND REPORTED ADVISED, ¿WHEN THE ANCHOR IS IMPLANTED, THE FRONT END FORKS AND IS SOFT, AND THE IMPLANTED PART OF THE ANCHOR BODY IS LONG. DURING THE POSITIONING PROCESS, THE DIRECTION IS PRONE TO DEVIATION, AND THE FRONT END BREAKS AFTER HITTING THE BONE." A COMPONENT HAD FALLEN INTO THE SURGICAL SITE AND WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 23837067 ↗
• MalfunctionDec 16, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE THAT THE Y1301 FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC), HI-FI SUTR DEVICE WAS BEING USED ON (B)(6) 2025. DURING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2025. WHEN IT WAS REPORTED ¿THE SMALL TEETH AT THE FRONT END BROKE.". FURTHER ASSESSMENT QUESTIONING FOUND THAT "THE INSERTER PART BROKE" AND THE FRAGMENTS WERE RETRIEVED WITH MEDICAL FORCEPS. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 23815593 ↗
• MalfunctionOct 21, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, Y1301, FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR, WAS BEING USED DURING A MBO PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿AFTER GUIDE INSERTION AND DRILLING, DURING THE PROCESS OF INSERTING THE ANCHOR TO THE BONE USING A MALLET, THE SUTURE BROKE WHILE PULLING IT OUT TO CHECK FIXATION. THE ANCHOR AND SUTURE WERE NOT RETURNED AS THEY WERE DISPOSED OF AT A HOSPITAL. AFTER PRODUCT INSPECTION, IT WAS FOUND THAT ONE UNIT HAD A BROKEN SHAFT". FURTHER ASSESSMENT THAT THE FRAGMENTATION OF THE DEVICE HAD FALLEN INTO THE SURGICAL SITE AND WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE CAUSING A 15-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 23346079 ↗
• MalfunctionJun 11, 2025Material Fragmentation; Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE Y1301, FLEX 1.3MM ALL SUTURE ANCH W/1-# 2 WHT/BL (5METRIC) HI-FI SUTR DEVICE WAS USED DURING GLENOID SURGERY ON (B)(6) 2025, AND ¿THE FRONT END OF THE IMPLANTATION ROD IS BROKEN.¿. FURTHER ASSESSMENT FOUND THE DEVICE FRAGMENTED, AND "A PART OF THE COMPONENT FALL INTO THE SURGICAL SITE.... THE FALLEN PARTS BEEN RETRIEVED¿ USING "SURGICAL TWEEZERS". THE PROCEDURE WAS COMPLETED AS NORMAL WITH THE USE OF AN ALTERNATE SAME DEVICE AND NO DELAY. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT OR USER, AND THE PAITENT'S CURRENT STATUS WAS DESCRIBED AS "RECOVERY". 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 22183169 ↗
• InjuryJun 10, 2025Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A REPORT FROM THE GERMAN HEALTH AUTHORITY, BFARM, CASE NUMBER (B)(4). THE REPORT WAS FORWARDED TO CONMED ON 26MAY25 FROM (B)(6) GMBH, WHO TRANSLATED THE REPORT FROM THE ORIGINAL GERMAN STATING THAT THE Y1301, FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR DEVICE WAS USED IN A SURGICAL PROCEDURE ON (B)(6) 2021 AND ¿DURING THE OPERATION, 2 ANCHORS WERE USED FOR THE LOWER FIXATION OF THE ROTATOR CUFF. THESE ANCHORS ARE SUPPLIED AS A COMPLETE SYSTEM BY THE COMPANY CONMED. WHEN INSERTING THESE ANCHORS, SMALL METAL PARTS OF 2 × 0.5 MM REMAINED IN MY CLIENT'S BONY TISSUE.¿. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. AS THE REPORT WAS PROVIDED WITH NO CONTACT INFORMATION FOR THE PATIENT OR USER, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A RETAINED FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22174766 ↗
• InjuryJun 10, 2025Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A REPORT FROM THE GERMAN HEALTH AUTHORITY, BFARM, CASE NUMBER (B)(4). THE REPORT WAS FORWARDED TO CONMED ON (B)(6) 2025 FROM MDSS GMBH, WHO TRANSLATED THE REPORT FROM THE ORIGINAL GERMAN STATING THAT THE Y1301, FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR DEVICE WAS USED IN A SURGICAL PROCEDURE ON (B)(6) 2021 AND ¿DURING THE OPERATION, 2 ANCHORS WERE USED FOR THE LOWER FIXATION OF THE ROTATOR CUFF. THESE ANCHORS ARE SUPPLIED AS A COMPLETE SYSTEM BY THE COMPANY CONMED. WHEN INSERTING THESE ANCHORS, SMALL METAL PARTS OF 2 × 0.5 MM ARE REMAINED IN MY CLIENT'S BONY TISSUE.¿. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. AS THE REPORT WAS PROVIDED WITH NO CONTACT INFORMATION FOR THE PATIENT OR USER, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A RETAINED FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22174763 ↗
• MalfunctionDec 19, 2024Material Fragmentation; Material Fragmentation

  CONMED INDIA REPORTED ON BEHALF OF A CUSTOMER THAT THE Y1301, FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2024 AND ¿2ND ANCHOR SAFAT BROKEN DURING THE SURGERIES¿. THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PATIENT. FURTHER ASSESSMENT WAS SENT, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN FURTHER INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. 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 20981391 ↗
• InjuryAug 26, 2024Material Fragmentation; Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR DEVICE WAS BEING USED DURING AN ARTHROSCOPIC LABRAL REPAIR PROCEDURE ON (B)(6) 2424, AND ¿AFTER THE Y1301 1.3MM YKNOT ANCHOR WAS INSERTED, IT WAS FOUND DISTAL TIP OF THE RIGHT SIDE WAS BROKEN, AND THE BROKEN TIP WAS RETAINED IN THE PATIENT'S BONE, CONFIRMED BY X- RAY.¿. PHOTOGRAPHS PROVIDED SHOW A TIP OF THE TWO-PRONGED METAL DRIVER IS MISSING. FOLLOW-UP ASSESSMENT FOUND "THE BROKEN TIP IS FULLY ANCHORED INTO THE BONE. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN TIP" AND DOES NOT INTEND TO REMOVE IT. THERE WAS NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE, WITH A DELAY OF 15 MINUTES. THERE WAS NO MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A RETAINED FOREIGN BODY IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20063949 ↗
• MalfunctionAug 13, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR, WAS BEING USED ON 1AUG24 AND ¿THE SURGERY WAS A BANKART REPAIR. THE SURGEON USESLSKI TWO 1.8 YKNOT FLEX ANCHOR AND FOR THE FINAL ANCHOR HE CHOSE AN 1.3MM YKNOT FLEX ANCHOR. HE DRILLED THE HOLE AND INSERTED AND DEPLOYED THE ANCHOR. POST DEPLOYMENT ON KNOT TYING HE SAW THE ENTIRE ANCHOR BAILED OUT ALSO THE GUIDE IS PRETTY STRAIGHT AND HE SAW A SMALL METAL TIP FROM THE GUIDE STUCK IN THE GLENOID. HE COMPLETED THE SURGERY USING ANOTHER 1.3MM YKNOT FLEX ANCHOR.". THERE WAS NO REPORT OF IMPACT OR INJURY FOR THE PATIENT. PER FURTHER ASSESSMENT IT WAS FOUND THAT THE SMALL METAL TIP WAS RETRIEVED FROM THE PATIENT. 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 19972249 ↗
• InjuryMar 13, 2024Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE (B)(6), Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR DEVICE WAS BEING USED ON (B)(6) 2024, AND ¿DURING SURGERY FOR BANKART REPAIR, THE SURGEON FOUND THAT 2MM METAL FORK TIP OF THE 1.3MM YKNOT FLEX INSERTION HANDLE WAS BROKEN AND WAS RETAINED INSIDE GLENOID BONE.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF STRYKER ICONIX ALL SUTURE ANCHORS AND WITH "ABOUT 20MINS DELAY IN SURGERY FOR WAITING THE X-RAY CONFIRMATION.". THERE WAS NO MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF THE REPORTED INJURY OF RETAINED FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18894404 ↗
• MalfunctionFeb 22, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WAS FOUND DURING PRE-OP TESTING ON 22JAN24 WHEN IT WAS REPORTED ¿ONE OF THE TIPS WAS BROKEN AND THE SUTURE WAS DETACHED WHEN A SURGEON OPENED A PACKAGE. THE BROKEN TIP AND DETACHED SUTURE HAVE NOT BEEN RETURNED AS THEY WERE DISPOSED OF AT A HOSPITAL.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. 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 18759635 ↗
• InjuryNov 8, 2023Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR, LOT NUMBER 1225797 OR 1232489 DEVICE WAS BEING USED DURING A SHOULDER LABRUM ANNULOPLASTY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED Y-KNOT FLEX WAS BROKEN DURING THE SURGERY. Y1301 WAS USED IN LABRUMPLASTY. THE FACILITY INSERTED IT INTO THE GLENOID FOSSA AS USUAL, AND WHEN THEY CHECKED THE TIP THAT CAME OUT, THEY FOUND THAT IT WAS BROKEN. THE SURGERY WAS COMPLETED WITHOUT REMOVING THE BROKEN PIECE. THERE ARE NO PLANS TO REMOVE IT IN THE FUTURE. "FURTHER ASSESSMENT QUESTIONING CONFIRMED THAT THERE ARE NO PLANS FOR REMOVAL OF THE FRAGMENTED DEVICE." THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS "UNKNOWN". THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THE FACILITY CANNOT CONFIRM WHICH LOT NUMBER WAS USED DURING THIS PROCEDURE. THIS REPORT SHALL BE WRITTEN AGAINST LOT NUMBER 1232489. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT RETAINING A FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18091524 ↗
• InjuryNov 8, 2023Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR, LOT NUMBER 1225797 OR 1232489 DEVICE WAS BEING USED DURING A SHOULDER LABRUM ANNULOPLASTY PROCEDURE ON 11OCT23 WHEN IT WAS REPORTED ¿Y-KNOT FLEX WAS BROKEN DURING THE SURGERY. Y1301 WAS USED IN LABRUMPLASTY. THE FACILITY INSERTED IT INTO THE GLENOID FOSSA AS USUAL, AND WHEN THEY CHECKED THE TIP THAT CAME OUT, THEY FOUND THAT IT WAS BROKEN. THE SURGERY WAS COMPLETED WITHOUT REMOVING THE BROKEN PIECE. THERE ARE NO PLANS TO REMOVE IT IN THE FUTURE.¿. FURTHER ASSESSMENT QUESTIONING CONFIRMED THAT THERE ARE NO PLANS FOR REMOVAL OF THE FRAGMENTED DEVICE.¿. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿UNKNOWN¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THE FACILITY CANNOT CONFIRM WHICH LOT NUMBER WAS USED DURING THIS PROCEDURE. THIS REPORT SHALL BE WRITTEN AGAINST LOT NUMBER 1225797. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT RETAINING A FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18091347 ↗
• MalfunctionSep 21, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WAS BEING USED DURING A SHOULDER INSTABILITY PROCEDURE ON (B)(6) 2023 DATE WHEN IT WAS REPORTED ¿UNCLEAR IF THE TIP OF THE DRIVER FELL INTO THE SURGICAL SITE OR IF IT FELL OUTSIDE THE SURGICAL SITE. THE SURGEON COULDN´T FIND THE TIP IN THE SURGICAL SITE. BUT THE SURGEON HAS DECIDED THAT THE PATIENT WILL UNDERGO AN X-RAY EXAMINATION AT THE NEXT RETURN VISIT. THE SURGERY WAS CARRIED OUT WITHOUT DELAY. TO THE BEST OF KATARINA'S KNOWLEDGE, THE PATIENT HAS NOT SUFFERED ANY DAMAGE BECAUSE OF WHAT HAPPENED. NO REPLACEMENT ANCHOR WAS USED. THE SURGEON LEFT THE ANCHOR WHOSE DRIVER (TIP) HAD BROKEN. THE SURGEON THEN SET TWO MORE ANCHORS OF THE SAME TYPE WHICH WORKED AS THEY SHOULD.¿. THE PROCEDURE WAS COMPLETED WITH THE SAME ALTERNATE DEVICE AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. 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 17789150 ↗
• MalfunctionSep 12, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR LOT NUMBER 1238822 WAS BEING USED DURING A BTB PROCEDURE ON 21AUG23 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 Y1802A, Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR LOT NUMBER 1309633 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 17728246 ↗
• InjurySep 8, 2023Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, Y1301, Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR, WAS BEING USED ON (B)(6) 2023 DURING A GLENOID LABRUMPLASTY AND THAT ¿¿IT WAS INSERTED INTO THE GLENOID AS USUAL AND THE SURGERY WAS COMPLETED. A POST-OPERATIVE X-RAY CONFIRMED THE PRESENCE OF METAL IN THE PATIENT'S BODY, CONFIRMING THAT ONE SIDE OF THE TIP OF Y1301 WAS BROKEN. THE DOCTOR EXPLAINS TO THE PATIENT THE NUMBER OF OUTBREAKS IN JAPAN, ETC., AND THE PATIENT UNDERSTANDS¿. FURTHER ASSESSMENT REVEALED THAT WHILE INSERTING THE ANCHOR, "NOTHING UNEXPECTED OCCURRED. THE DEVICE COULD BE USED AS USUAL". THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATIVE DEVICE AND NO REPORTED DELAY. THERE WAS ¿NO MEDICAL/SURGICAL INTERVENTION REPORTED¿, ¿NO REPORTED EXTENDED STAY", AND A "2ND SURGERY IS NOT SCHEDULED". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF DEVICE FRAGMENTATION LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17712565 ↗
• InjuryDec 31, 2019Material Fragmentation; Material Fragmentation

  CONMED KOREA REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE Y1301, Y-KNOT FLEX ANCHOR INSERTER BROKE DURING A SLAP ARTHROSCOPIC PROCEDURE ON (B)(6) 2018. A SURGEON CREATED A PILOT HOLE USING Y13D AND ADVANCED THE Y-KNOT ANCHOR INTO THE PILOT HOLE UNTIL THE HANDLE OF THE ANCHOR COMES INTO CONTACT WITH THE PROXIMAL END OF THE DRILL GUIDE. THE SURGEON RELEASED THE SUTURE FROM THE DRIVER AND PULLED OUT THE DRIVER. THE DRIVER AND DRILL BIT WERE DISPOSED OF AT THE HOSPITAL. SURGERY WAS COMPLETED SUCCESSFULLY AT THAT TIME. IT IS UNKNOWN IF THE SURGICAL TEAM WAS AWARE OF THIS AT THE TIME. A YEAR AFTER SURGERY, THE PATIENT FOUND OUT THAT THERE IS THE PART OF THE DRIVER TIP INSIDE THE SHOULDER BONE, WHEN THEY WENT TO ANOTHER HOSPITAL AND HAD X-RAYS PERFORMED ON (B)(6). THE PATIENT INFORMED THE SURGEON AND THE SURGEON REQUESTED THAT NEW X-RAYS BE DONE AT THE ORIGINAL HOSPITAL. THE SURGEON USED 5 OF Y1301, Y-KNOT SUTURE ANCHORS, DURING SURGERY, HOWEVER, ONLY ONE OF THEM, THE END OF DRIVER TIP WAS BROKEN. SO THE SURGEON REPORTED ALL OF THE ONES USED TO THE PATIENT'S SURGERY. THIS REPORT IS BEING RAISED BASED ON PATIENT INJURY DUE TO THE METAL FRAGMENT REMAINING IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9535489 ↗
• InjuryNov 5, 2019Material Fragmentation; Material Fragmentation

  (B)(6) CONMED REPORTED ON BEHALF OF THEIR FACILITY THAT THE Y1301, Y-KNOT SUTURE ANCHOR'S INSERTER WAS MISSING THE PRONGS. DURING AN ARTHROSCOPIC SHOULDER STABILIZATION ON (B)(6) 2019 THE SCRUB NURSE CHECKED THE Y-KNOTS AT END OF INSERTION AND NOTED ONE OF THE METAL PRONGS WAS MISSING. THE SURGEON WAS NOTIFIED. THE SURGEON CONTINUED WITH THE OPERATION AND SEARCHED FOR THE MISSING PRONG. NOTHING WAS FOUND. THE NURSE MANAGER WAS INFORMED AND REQUESTED AN X-RAY TO BE DONE PRIOR TO CLOSING. THE X-RAY WAS DONE. THE METAL PRONG WAS IDENTIFIED AS BEING IN THE PATIENT'S BONE. THE SURGEON MADE AN INFORMED DECISION TO LEAVE THE PRONG INSITU AS AN ATTEMPT TO GET IT OUT COULD CAUSE INJURY TO THE PATIENT. THE INCIDENT WAS DOCUMENTED IN PATIENT'S NOTES AND THE PATIENT WAS INFORMED BY SURGEON. THIS REPORT IS BEING RASIED FOR PATIENT INJURY, DUE TO METAL FRAGMENT BEING RETAINED IN THE BONE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9279716 ↗
• MalfunctionApr 23, 2019Material Fragmentation; Material Fragmentation

  ON BEHALF OF THE CUSTOMER, THE CONMED SALES REPRESENTATIVE REPORTED ISSUES WITH THE Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE #2 WHITE/BLUE HI-FI SUTURE, ITEM # Y1301, LOT # 989333 THAT OCCURRED (B)(6) 2019 AT CHIR. ZENTRUM DURING A LABRUM REFIXATION PROCEDURE INVOLVING A (B)(6) YEAR OLD MALE WEIGHING (B)(6) KG. IT WAS REPORTED "DURING DRIVING THE METAL PEAK OF THE ANCHOR WAS BROKEN AT THE FORK. THE METAL PIECE WAS REMOVED FROM THE PATIENT WITHOUT INJURY." IT IS INDICATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATE Y1301 BUT WITH A 30-MINUTE DELAY. ADDITIONAL INFORMATION OBTAINED INDICATES THAT THE ISSUE OCCURRED AT THE END OF THE PROCEDURE WHILE PLACING THE FIRST SUTURE ANCHOR. THE METAL PIECE WAS RETRIEVED WITH GRASPING FORCEPS AND THE PHYSICIAN CONFIRMED THAT ALL THE PIECES WERE REMOVED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE (THE FRAGMENTATION OF THE DEVICE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8539490 ↗
• InjuryJun 25, 2018Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE Y1301, Y-KNOT FLEX 1.3 MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE (5 METRIC) HI-FI SUTURE, DEVICE TINE (TIP) ON THE DRIVER BROKEN WHILE INSERTING THE ANCHOR DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2018. THE TINE WAS LODGED IN THE PATIENT'S GLENOID. THE TINE WAS NOT RETRIEVED PER THE REPORTER. THIS EVENT DID NOT CAUSE A DELAY OR CANCELLATION OF THE PROCEDURE. THE PATIENT WAS REPORTED AS NOT HAVING ANY INJURY; NOR WAS THERE ANY SURGICAL INTERVENTION OR EXTENDED STAY IN THE HOSPITAL FOR THIS EVENT. THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE TIP NOT BEING RETRIEVED FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7635619 ↗
• MalfunctionJun 25, 2018Break; Break

  THIS DISTRIBUTOR REPORTED THAT THE Y1301, Y-KNOT FLEX 1.3 MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE (5 METRIC) HI-FI SUTURE, DRIVER TIP WAS BROKEN IN THE PATIENT WHILE THE ANCHOR WAS BEING PLACED BY USING A MALLET ON THE DRIVER DURING A SLAP PROCEDURE ON (B)(6) 2018. THE BROKEN TIP WAS REMOVED FROM PATIENT USING 16.1018 FORCEPS. THE REPORTER HAS STATED THAT THERE WAS NO INJURY TO THE PATIENT OR THE USER. THERE WAS NO HOSPITALIZATION OR EXTENDED STAY FOR THE PATIENT DUE TO THIS EVENT. THE PATIENT IS REPORTED TO BE IN GOOD/STABLE CONDITION. THE PROCEDURE WAS COMPLETED USING ANOTHER Y1301. 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 7634739 ↗
• InjuryJun 5, 2018Break; Break

  THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A DISTAL BICEP REPAIR, THE SURGEON INSERTED TWO Y1301 Y-KNOT FLEX ANCHORS INTO THE BICIPITAL TUBEROSITY AFTER PREVIOUSLY DRILLING THE HOLES WITH THE STANDARD GUIDE. AFTER INSERTING THE ANCHORS, WHILE REMOVING THE DRIVER AND PULLING ON THE SUTURE TO SEAT THE ANCHOR, THE NURSE NOTICED THAT ONE OF THE FORKS ON BOTH ANCHOR'S DRIVERS HAD BROKEN OFF. THERE WERE NO ISSUES REPORTED WITH THE ANCHORS, AS THEY WERE CORRECTLY SEATED WITH THE SUTURE. THE SURGEON CONDUCTED A SEARCH FOR THE FORKS, BUT WAS UNABLE TO LOCATE THE FORK TIPS. THE SURGICAL TEAM CONCLUDED THE BROKEN PIECE WAS WASHED AND SUCTIONED. THE PROCEDURE WAS COMPLETED WITH A 2 MINUTE SURGICAL DELAY AND NO REPORTED PATIENT INJURY. THIS REPORT IS BEING RAISED ON THE BASIS OF THE LOCATION OF A BROKEN PIECE OF A NON IMPLANTABLE DEVICE BEING UNKNOWN. THE OTHER REPORTED Y1301 Y-KNOT FLEX IS BEING REPORTED UNDER MDR 1017294-2018-00076.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7568602 ↗
• InjuryJun 5, 2018Break; Break

  THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A DISTAL BICEP REPAIR, THE SURGEON INSERTED TWO Y1301 Y-KNOT FLEX ANCHORS INTO THE BICIPITAL TUBEROSITY AFTER PREVIOUSLY DRILLING THE HOLES WITH THE STANDARD GUIDE. AFTER INSERTING THE ANCHORS, WHILE REMOVING THE DRIVER AND PULLING ON THE SUTURE TO SEAT THE ANCHOR, THE NURSE NOTICED THAT ONE OF THE FORKS ON BOTH ANCHOR'S DRIVERS HAD BROKEN OFF. THERE WERE NO ISSUES REPORTED WITH THE ANCHORS, AS THEY WERE CORRECTLY SEATED WITH THE SUTURE. THE SURGEON CONDUCTED A SEARCH FOR THE FORKS, BUT WAS UNABLE TO LOCATE THE FORK TIPS. THE SURGICAL TEAM CONCLUDED THE BROKEN PIECE WAS WASHED AND SUCTIONED. THE PROCEDURE WAS COMPLETED WITH A 2 MINUTE SURGICAL DELAY AND NO REPORTED PATIENT INJURY. THIS REPORT IS BEING RAISED ON THE BASIS OF THE LOCATION OF A BROKEN PIECE OF A NON IMPLANTABLE DEVICE BEING UNKNOWN. THE OTHER REPORTED Y1301 Y-KNOT FLEX IS BEING REPORTED UNDER MDR 1017294-2018-00075.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7568577 ↗