ENDOBUTTON 72200146Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010597250), received between Dec 5, 2017 and Jun 19, 2025 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN ACROMIOCLAVICULAR JOINT DISLOCATION SURGERY HAD BEEN PERFORMED ON A (B)(6), 2025, IN WHICH THE ENDOBUTTON WAS USED, THE PATIENT UNDERWENT A REVISION DEBRIDEMENT SURGERY ON AN (B)(6), 2025 DUE TO REDNESS, SWELLING AND ABNORMAL EXUDATION. THE WOUND HEALED WELL AFTER THE SURGERY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 22288781 ↗
• MalfunctionDec 30, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PACKAGE OF THE 15 MM ENDOBUTTON ULTRA WAS ALREADY OPEN AND FELL TO THE GROUND AFTER UNPACKING. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035826 ↗
• MalfunctionJul 17, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGE OF THE ENDOBUTTON WAS DAMAGED, THE IMPLANT WAS NON-STERILE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763320 ↗
• MalfunctionJun 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, WHEN TIGHTENING THE SUTURE LOOP OF THE ENDOBUTTON, THE BONE TUNNEL GOT DAMAGE, IN THE TENDON TRACTION, THE BONE CANAL CRACKED AND COULD NO LONGER FIXED WITH TABS. THE PROCEDURE WAS COMPLETED USING A DIFFERENT SURGICAL TECHNIQUE (COMPRESSION OF BIOSURE DEVICE FIXATIONS) IN THE ORIGINALLY DRILLED HOLE, WITH A NON-SIGNIFICANT SURGICAL DELAY. AFTER THE SURGERY, NO DAMAGE WAS FOUND TO THE PATIENT AND NO COMPLICATIONS WERE FOUND. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172900 ↗
• InjuryApr 4, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BONE OF THE ENDOBUTTON'S BONE TUNNEL BROKE INSIDE THE PATIENT WHILE PULLING THE SUTURE. A CHANGE IN THE SURGICAL TECHNIQUE, IN WHICH INTERFERENCE SCREWS WERE USED TO FIX THE ENDS, WAS PERFORMED. A NON-SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 16677257 ↗
• InjuryMar 24, 2023Insufficient Device Problem Information; Physical Resistance/Sticking; Insufficient Device Problem Information; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, WHEN TIGHTENING THE SUTURE LOOP OF THE ENDOBUTTON, THE BONE TUNNEL GOT DAMAGE. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE USING BIOSURE DEVICE FIXATIONS OF BOTH ENDS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612138 ↗
• InjuryDec 16, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A THE LIGAMENT REPAIR SURGERY, WHEN TIGHTENING THE SUTURE LOOP OF THE ENDOBUTTON, THE BONE HOLE WAS DAMAGE, IT BREAK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY BY CHANGING THE SURGICAL TECHNIQUE USING BIOSURE DEVICE FIXATIONS OF BOTH ENDS. PATIENT STATUS IS REPORTED TO BE GOOD AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996564 ↗
• 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 (B)(6) 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 15848460 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "AUGMENTATION OF PRIMARY ACL RECONSTRUCTION WITH A MODIFIED ELLISON LATERAL EXTRA-ARTICULAR TENODESIS IN HIGH-RISK PATIENTS", 1 PATIENT HAD RECURRENT KNEE EFFUSIONS 10 MONTHS AFTER AN ACL RECONSTRUCTION PROCEDURE USING AN ENDOBUTTON DEVICE. THE EVENT WAS TREATED WITH AND ARTHROSCOPIC DEBRIDEMENT OF A CYCLOPS LESION. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s)

  MAUDE report 15728570 ↗
• MalfunctionOct 25, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP FOR AN ARTHROSCOPY PROCEDURE, THE ENVELOPE OF THE ENDOBUTTON DEVICE WAS ALREADY OPEN; THEREFORE, IT WAS NOT STERILE ANYMORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694439 ↗
• MalfunctionJun 1, 2021Contamination; Contamination

  IT WAS REPORTED THAT, WHEN OPENING THE "15MM ULTRABUTTON, CL ULTRA" PACKAGE, IT WAS FOUND A FOREIGN BODY INSIDE THE PACKAGE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY OR IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913997 ↗
• InjuryDec 1, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, ENDOBUTTON THREAD BROKE AT THE MOMENT OF TRACTION OF THE BUTTON. THE BUTTON WAS REMOVED WITH FORCEPS, ALL THE PIECES WERE SUCCESSFULLY REMOVED FROM PATIENT WITH FORCEPS. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10930373 ↗
• MalfunctionOct 31, 2020Break; Break

  IT WAS REPORTED THAT THE FIBER IN THE ENDOBUTTON LOOP WAS BROKEN. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE AND IF THE EVENT HAPPENED DURING SURGERY. NO 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 Information

  MAUDE report 10767290 ↗
• InjuryAug 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING CL RECONSTRUCTION SURGERY, WHEN THE TENDON TRACTION WAS BEING PERFORMED, THE LOOP OF THE ENDOBUTTON WAS CUT AND BROKEN BY THE BONE SURFACE. THE BONE DID NOT SUFFER ANY DAMAGE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 Information

  MAUDE report 10426670 ↗
• MalfunctionMay 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE ENDOBUTTON STRING APPEARED TO HAVE BEEN WEAK AND RIPPED PRIOR TO INSERTION INTO PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY (5 MINUTES) 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 Known Impact Or Consequence To Patient

  MAUDE report 10038796 ↗
• MalfunctionMar 22, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING THE PROCEDURE AT THE TIME OF USING THE DEVICE THE PHYSICIAN REALIZED THE PACKAGE WAS OPEN AND EMPTY. THE PROBLEM WAS SOLVED BY USING A BACK UP DEVICE ( A LARGER ENDOBUTTON SIZE ) ON THE PATIENT IN ORDER TO FINISH THE PROCEDURE. NO INJURIES WERE REPORTED. THERE WAS A DELAY GREATER THAN TWO HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7364451 ↗
• InjuryDec 5, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER USE THE DEVICE TO FIX FOR ACROMIOCLAVICULAR JOINT REDUCTION PURPOSE AS THE PATIENT HAD AN ACROMIOCLAVICULAR JOINT THIRD-DEGREE DISLOCATION. IT WAS FOUND THAT THE ENDOBUTTON LOST ITS FIXATION, SO THE PATIENT HAD TO ACCEPT A SECOND SURGERY.

  Patient problems: Failure of Implant; Joint Dislocation; No Code Available

  MAUDE report 7084555 ↗