Double ENDOBUTTONRecalls & reported problems across all models

We found 2 models of Double ENDOBUTTON by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Sep 1, 2020 and Jan 27, 2026 — classified as 21 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Double ENDOBUTTON problems

Double ENDOBUTTON models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Double ENDOBUTTON 71934993

  WASHER, BOLT NUT
  18 reports
• Double ENDOBUTTON 71934990

  WASHER, BOLT NUT
  11 reports

Recent Double ENDOBUTTON adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionOct 28, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE A PROCEDURE, DURING THE PRODUCT OPENING PHASE, THE ROUND ENDOBUTTON PRIMARY PACKAGING WAS FOUND TO BE OPEN. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407376 ↗
• MalfunctionAug 25, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE SUTURE OF TWO (2) ROUND ENDOBUTTONS WAS BROKEN AND THE DEVICES FELL OFF THE BONE. SURGERY WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE INSTEAD. 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 22883407 ↗
• 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 15316851 ↗
• 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 15316780 ↗
• 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 15316776 ↗
• 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 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 15316337 ↗

Other Smith & Nephew, Inc. products

• FAST-FIX18 models · 9,554 reports
• JOURNEY566 models · 6,250 reports · 4 recalls
• GENESIS II462 models · 4,599 reports · 2 recalls
• DYONICS, POWERMAX, ELITE2 models · 4,308 reports
• TRIGEN381 models · 3,599 reports · 5 recalls
• LEGION446 models · 2,039 reports · 4 recalls
• REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
• Coblation62 models · 2,126 reports