ENDOBUTTON 72200147Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010597267), received between Aug 8, 2017 and Mar 26, 2026 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE ENDOBUTTON BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696123 ↗
• MalfunctionAug 18, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A PROCEDURE THE ENDOBUTTON ULTRA 20MM BOX WAS OPENED AND THERE WAS NO IMPLANT INSIDE THE BOX, CONTAINING ONLY STICKERS AND A BOOKLET, THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE, THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825010 ↗
• MalfunctionAug 11, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE BOX OF THE 20MM ENDOBUTTON ULTRA WAS OPENED, IT WAS NOTICED THAT THERE WAS NO IMPLANT INSIDE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770769 ↗
• MalfunctionAug 11, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE BOX OF THE 20MM ENDOBUTTON ULTRA WAS OPENED, IT WAS NOTICED THAT THERE WAS NO IMPLANT INSIDE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770688 ↗
• InjuryMar 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ULTRA ENDOBUTTON TRACTION SUTURE BROKE, THE SUTURE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526010 ↗
• InjuryJan 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, SIX WEEKS AFTER A LEFT KNEE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY + ARTHROSCOPIC MENISCUS SHAPING SURGERY + ARTHROSCOPIC KNEE SYNOVECTOMY SURGERY + TENDON EXCISION SURGERY + JOINT THERAPEUTIC SUBSTANCE INJECTION, WHICH WAS PERFORMED ON (B)(6) 2024 AND IN WHICH A 20 MM ENDOBUTTON CL ULTRA WAS INSERTED, THE PATIENT HAD POOR WOUND HEALING. ON (B)(6) 2024, UNDER GENERAL ANESTHESIA, A DEBRIDEMENT AND VSD DRAINAGE WERE PERFORMED FOR POOR WOUND HEALING AFTER THE PRIMARY SURGERY OF THE LEFT ANTERIOR CRUCIATE LIGAMENT. ON (B)(6) 2024, APPROXIMATELY, THE PATIENT EXPERIENCED RECURRENT FEVER WITH A MAXIMUM TEMPERATURE OF 38.5 DEGREES CELSIUS AND THE BLOOD TEST RESULTS SHOWED 80.5% NEUTROPHILS AND 141.89MG/L C-REACTIVE PROTEIN. THE PATIENT WAS TREATED WITH VANCOMYCIN 1.0G Q12H. ON (B)(6) 2024, UNDER GENERAL ANESTHESIA, THE PATIENT UNDERWENT ARTHROSCOPIC CLEANING OF THE LEFT KNEE SURGERY WITH POOR WOUND HEALING. DURING THIS REVISION SURGERY, PURULENT FLUID ACCUMULATION AND SYNOVIAL INFECTION WERE OBSERVED IN THE KNEE JOINT, AND THE ANTERIOR CRUCIATE LIGAMENT GRAFT FAILED. KNEE JOINT SYNOVIAL CLEANING WAS PERFORMED, AND A DRAINAGE TUBE WAS PLACED. THE ANCHOR REMA

  Patient problems: Fever; Impaired Healing; Synovitis

  MAUDE report 21134449 ↗
• MalfunctionMar 21, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE STERILE FOIL OF THE ENDOBUTTON WAS NOT WELL AFFIXED, THE IMPLANT WAS NON-STERILE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. IT UNKNOWN IF THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952177 ↗
• MalfunctionFeb 19, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN OPENING THE PACKAGING OF THE ENDOBUTTON ULTRA, THE NURSE NOTICED THAT THE PACKAGING HAD A HOLE IN IT. THE SAME PROBLEM WAS FOUND ON A SECOND PACKAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731387 ↗
• MalfunctionMay 3, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING SET UP FOR AN ACL RECONSTRUCTION SURGERY, ONCE THE PACKAGE OF THE ENDOBUTTON DEVICE WAS OPENED, IT WAS FOUND THE ASEPTIC POUCH WAS DAMAGED. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863891 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, AN UNKNOWN AMOUNT OF PATIENTS REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING ENDOBUTTON DEVICES. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15848647 ↗
• MalfunctionAug 24, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE CARTON OF THE ENDOBUTTON WAS OPENED, IT WAS FOUND THAT THE STERILE PACKAGE HAD BEEN DAMAGED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15286688 ↗
• InjuryJul 27, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY USING ENDOBUTTON, THE WHITE SUTURE BROKE UNDER THE STRAIN, THE CLOSED-LOOP OF THE ENDOBUTTON WAS CUT BECAUSE THE PLATES COULD NOT BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 30 MINUTES USING A BACK-UP DEVICE. THE PLATE WAS REMOVED FROM THE PATIENT AND AN ADDITIONAL BONE HOLE WAS REQUIRED TO COMPLETE THE SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED. CURRENT HEALTH STATUS IS GOOD, PATIENT HAS BEEN DISCHARGED.

  Patient problems: Perforation; Rupture

  MAUDE report 15117867 ↗
• MalfunctionNov 11, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, WHEN OPENING THE BOX OF THE ENDOBUTTON, IT WAS NOTICED THAT THERE WAS NOT IMPLANT OR STICKY LABELS IN THE BOX. ONLY THE INSTRUCTIONS FOR USE WAS IN THE BOX. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10825484 ↗
• MalfunctionJan 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PCL PROCEDURE, WHEN PULLING THE GRAFT, LOOP OF THE ENDOBUTTON CL GOT RUPTURED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9581000 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A KNEE PROCEDURE, PATIENT EXPERIENCED A PAIN, SWELLING AND MICRO BLOODY EXUDATION IN THE OPERATION AREA. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR IF A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Pain; Swelling

  MAUDE report 8701050 ↗
• MalfunctionJan 3, 2019Break

  IT WAS REPORTED THAT DURING THE SURGERY WHILE IMPLANTING THE TUNNEL, THE CLUSTER OF THE LOOP BROKE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8214553 ↗
• MalfunctionOct 25, 2018Expiration Date Error

  IT WAS REPORTED THAT AN EXPIRED ENDOBUTTON CL WAS IMPLANTED ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005199 ↗
• MalfunctionMay 28, 2018Material Frayed

  IT WAS REPORTED THAT DURING PROCEDURE THE SURGEON FELT THAT THE CONDITION OF GRAFT WAS NOT GOOD COMPARED WITH USUAL. WHEN THE GRAFT WAS PULLED UP INTO PREPARED BONE SITE, ENDOBUTTON CL WAS CHECKED OUTSIDE FEMORAL BONE SITE AND IT WAS FRAYED. THEN GRAFT WAS PULLED UP FOR FIXING. FOR FINAL CHECK OF FIXING, WHEN SUTURE WAS PULLED UP, GRAFT WAS CUT AND CAME OUT FROM BONE SITE. THEREFORE, ENDOBUTTON CL WAS GOT BACK AND FOUND THAT PART OF CL DAMAGED AND CUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7547796 ↗
• MalfunctionMay 20, 2018Break

  IT WAS REPORTED THAT THE SUTURE BROKE WHEN IT WAS PULLED THROUGH THE FEMORAL TUNNEL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7528650 ↗
• MalfunctionAug 8, 2017Break; Difficult to Remove

  IT WAS REPORTED THAT THE GUIDE WIRE BROKE DURING THE PROCEDURE. THIS WAS NOT NOTICED UNTIL THE END OF THE PROCEDURE. SURGERY TIME WAS EXTENDED IN AN UNSUCCESSFUL ATTEMPT TO RETRIEVE THE BROKEN PIECE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6774126 ↗