Double ENDOBUTTON 71934990Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556486191), received between Sep 1, 2020 and Oct 28, 2025 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 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 ↗
• 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 15314546 ↗
• InjuryAug 17, 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 15242689 ↗
• 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 10480303 ↗
• 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; Joint Dislocation; Osteolysis

  MAUDE report 10480237 ↗
• 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; Osteolysis

  MAUDE report 10480123 ↗