Double ENDOBUTTON 71934993Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885556424544), received between Sep 1, 2020 and Jan 27, 2026 — classified as 12 injuries, 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Migration; Material Split, Cut or Torn

  IT WAS REPORTED THAT, ONE WEEK AFTER A DISLOCATION SURGERY WAS PERFORMED, ON (B)(6) 2025, IT WAS DISCOVERED ON AN X-RAY THAT THE ROUND ENDOBUTTON BECAME DISLODGED DUE TO LOOSENING OR RUPTURE OF THE ARTIFICIAL LIGAMENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO RESOLVE THIS, DURING WHICH A COMPETITOR DEVICE WAS USED. PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24188451 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING A LATERJET PROCEDURE, THE THREAD OF A ROUND ENDOBUTTON BROKE WHILE TENSIONING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756924 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A BONE BLOCK SURGERY, THE SUTURE OF TWO (2) ENDOBUTTONS GOT BROKEN WHILE TENSIONING AT 90NEWTON IN THE TENSIONER DEVICE WHILE FINAL CLOSER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A DIFFERENT TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846275 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ENDOBUTTON SUTURE THAT WAS HOLDING THE IMPLANT FIXED TO THE PORTION OF THE CHOROID TO THE ANTERIOR PORTION OF THE GLENOID WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF MORE THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630591 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED THAT DURING DOUBLE ENDOBUTTON FIXATION, BREAKAGE OF THE ROUND ENDOBUTTON OF ONE (1) RND ENDBTN POST SST W-SZ3/4 SUTURE LOOP DUE TO SNAGGING DURING TENSIONING. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532146 ↗
• MalfunctionAug 21, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, AFTER THE GRAFT AND THE ENDOBUTTON WERE PLACED ON THE GLENOID, THE LOOP WAS NOT SLIDING AND THE SURGEON WAS NOT ABLE TO PUT A KNOT. THE IMPLANT HAD TO BE REMOVED WITH THE HELP OF A GRASPER, TWEEZER, AND SUTURE RETRIEVER. THE LOOP WAS DAMAGED IN THE PROCESS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17590214 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "SCREW VERSUS DOUBLE ENDOBUTTON FIXATION OF THE ALLOGRAFT FOR ARTHROSCOPIC ANATOMIC GLENOID RECONSTRUCTION IN THE TREATMENT OF RECURRENT ANTERIOR SHOULDER DISLOCATION", 1 PATIENT HAD A RE-DISLOCATION AFTER A GLENOID BONE REPAIR PROCEDURE USING A ROUND ENDOBUTTON DEVICE. THE DISLOCATION WAS RESOLVED WITH A GLENOID RECONSTRUCTION USING DISTAL TIBIA ALLOGRAFT WITH SCREW FIXATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15316785 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "SCREW VERSUS DOUBLE ENDOBUTTON FIXATION OF THE ALLOGRAFT FOR ARTHROSCOPIC ANATOMIC GLENOID RECONSTRUCTION IN THE TREATMENT OF RECURRENT ANTERIOR SHOULDER DISLOCATION", 1 PATIENT HAD A RE-DISLOCATION AFTER A GLENOID BONE REPAIR PROCEDURE USING A ROUND ENDOBUTTON DEVICE. THE DISLOCATION WAS RESOLVED WITH A GLENOID RECONSTRUCTION USING DISTAL TIBIA ALLOGRAFT WITH SCREW FIXATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15316768 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "SCREW VERSUS DOUBLE ENDOBUTTON FIXATION OF THE ALLOGRAFT FOR ARTHROSCOPIC ANATOMIC GLENOID RECONSTRUCTION IN THE TREATMENT OF RECURRENT ANTERIOR SHOULDER DISLOCATION", A PATIENT HAD A RE-DISLOCATION AFTER A GLENOID BONE REPAIR PROCEDURE USING A DOUBLE ENDOBUTTON DEVICE. THE PATIENT WAS REVISED TO A GLENOID RECONSTRUCTION USING DISTAL TIBIA ALLOGRAFT WITH SCREW FIXATION. PATIENT IS DOING WELL POST-OPERATIVELY SINCE THE REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15316559 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "SCREW VERSUS DOUBLE ENDOBUTTON FIXATION OF THE ALLOGRAFT FOR ARTHROSCOPIC ANATOMIC GLENOID RECONSTRUCTION IN THE TREATMENT OF RECURRENT ANTERIOR SHOULDER DISLOCATION"; 1 PATIENT HAD A RE-DISLOCATION AFTER A GLENOID BONE REPAIR PROCEDURE USING A ROUND ENDOBUTTON DEVICE. THE DISLOCATION WAS RESOLVED WITH A GLENOID RECONSTRUCTION USING DISTAL TIBIA ALLOGRAFT WITH SCREW FIXATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15314531 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "SCREW VERSUS DOUBLE ENDOBUTTON FIXATION OF THE ALLOGRAFT FOR ARTHROSCOPIC ANATOMIC GLENOID RECONSTRUCTION IN THE TREATMENT OF RECURRENT ANTERIOR SHOULDER DISLOCATION", 1 PATIENT HAD A RE-DISLOCATION AFTER A GLENOID BONE REPAIR PROCEDURE USING THREE (3) ROUND ENDOBUTTON DEVICES. THE DISLOCATION WAS RESOLVED WITH A GLENOID RECONSTRUCTION USING DISTAL TIBIA ALLOGRAFT WITH SCREW FIXATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15312619 ↗
• InjuryApr 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE SURGEON DRILLED DIRECTLY THROUGH A SUTURE ON THE 'ENDOBUTTON'. AS A RESULT, ONLY A HALF-HITCH COULD BE MADE, AND THE SUTURE WAS UNDER TENSIONED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR MITEK SCREW MOVING TO AN OPEN EDEN-HYBINETTE TECHNIQUE, BUT NOT DUE TO A S+N PRODUCT FAILURE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219887 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "SCREW VERSUS DOUBLE ENDOBUTTON FIXATION OF THE ALLOGRAFT FOR ARTHROSCOPIC ANATOMIC GLENOID RECONSTRUCTION IN THE TREATMENT OF RECURRENT ANTERIOR SHOULDER DISLOCATION," 6 PATIENTS HAD A RE-DISLOCATION AFTER A GLENOID BONE REPAIR PROCEDURE USING A DOUBLE ENDOBUTTON DEVICE. IT IS UNKNOWN HOW THESE EVENTS WERE TREATED. PATIENTS OUTCOME IF KNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13623419 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A GLENOID BONE LOSS SURGERY, A REVISION HAD TO BE PERFORMED. THE SURGEON NOTED EXCESSIVE RESORPTION ON THE DISTAL TIBIAL ALLOGRAFT ASSOCIATED WITH THE USE OF THE ROUND ENDOBUTTON, AS COMPARED TO THE RESORPTION WHEN USING SCREW FIXATION. THE RESORPTION WAS NOTED IN THE 2 YEAR FOLLOW-UP MRI AND CONFIRMED DURING THE REVISION SURGERY. THE PATIENT'S OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Injury; Joint Dislocation; Osteolysis

  MAUDE report 10613353 ↗
• MalfunctionOct 1, 2020Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A GLENOID BONE LOSS SURGERY, A REVISION HAD TO BE PERFORMED. THE SURGEON NOTED EXCESSIVE RESORPTION ON THE DISTAL TIBIAL ALLOGRAFT ASSOCIATED WITH THE USE OF THE ROUND ENDOBUTTON, AS COMPARED TO THE RESORPTION WHEN USING SCREW FIXATION. THE RESORPTION WAS NOTED IN THE 2 YEAR FOLLOW-UP MRI AND CONFIRMED DURING THE REVISION SURGERY. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information; Joint Dislocation; Osteolysis

  MAUDE report 10613277 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A GLENOID BONE LOSS SURGERY, A REVISION HAD TO BE PERFORMED. THE SURGEON NOTED EXCESSIVE RESORPTION ON THE DISTAL TIBIAL ALLOGRAFT ASSOCIATED WITH THE USE OF THE ROUND ENDOBUTTON, AS COMPARED TO THE RESORPTION WHEN USING SCREW FIXATION. THE RESORPTION WAS NOTED IN THE 2 YEAR FOLLOW-UP MRI AND CONFIRMED DURING THE REVISION SURGERY. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Injury; Joint Dislocation; Osteolysis

  MAUDE report 10480267 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A GLENOID BONE LOSS SURGERY, A REVISION HAD TO BE PERFORMED. THE SURGEON NOTED EXCESSIVE RESORPTION ON THE DISTAL TIBIAL ALLOGRAFT ASSOCIATED WITH THE USE OF THE ROUND ENDOBUTTON, AS COMPARED TO THE RESORPTION WHEN USING SCREW FIXATION. THE RESORPTION WAS NOTED IN THE 2 YEAR FOLLOW-UP MRI AND CONFIRMED DURING THE REVISION SURGERY. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Injury; Joint Dislocation; Osteolysis

  MAUDE report 10480186 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A GLENOID BONE LOSS SURGERY, A REVISION HAD TO BE PERFORMED. THE SURGEON NOTED EXCESSIVE RESORPTION ON THE DISTAL TIBIAL ALLOGRAFT ASSOCIATED WITH THE USE OF THE ROUND ENDOBUTTON, AS COMPARED TO THE RESORPTION WHEN USING SCREW FIXATION. THE RESORPTION WAS NOTED IN THE 2 YEAR FOLLOW-UP MRI AND CONFIRMED DURING THE REVISION SURGERY. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10480075 ↗