ULTRABUTTON 72205443Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556817179), received between Jul 17, 2024 and Sep 3, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, UPON PASSING THE GRAFT UP INTO THE FEMORAL AND TIBIAL TUNNELS, ONCE THE BUTTON HAD FLIPPED, THE SURGEON WENT TO REDUCE THE GRAFT USING REDUCING SUTURES AND ONE SUTURE BROKE OFF AT THE BUTTON WITH THE INITIAL TENSION BEFORE REDUCING. THE SURGEON CUT DOWN TO THE BUTTON FROM THE LATERAL SIDE OF THE LEG AND MANAGED TO FEED SUTURE BACK THROUGH BUTTON. THE BUTTON WAS ABLE TO BE REDUCED, AND GRAFT LOOKED SOLID ON THE SCREEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956208 ↗
• MalfunctionJul 30, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP, THE PACKAGE OF THE ULTRABUTTON WAS COMPROMISED, IT SEEMED NOT PERFECTLY SEALED (CUSTOMER REPORTED STERILE PACKAGING DAMAGED AND PROBABLY COMPROMISED). THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669067 ↗
• MalfunctionJan 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE PULLING THE GRAFT OF THE ULTRABUTTON THROUGH THE TUNNEL, THE SUTURE WAS CUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIGNIFICANT SURGICAL DELAY OF MORE THAN 30 MINUTES USING A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260958 ↗
• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ULTRABUTTON QUAD FIXATION SUTURE BROKE WHILE TRYING TO PULL INSIDE THE TUNNEL. THE WHOLE GRAFT ALONG WITH THE IMPLANT WAS TAKEN OUT AND THEN THE IMPLANT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A SCREW TO FIX THE GRAFT. IT WAS NECESSARY TO DRILL AN ADDITIONAL BONE HOLE, THEREFORE, A VOID WAS LEFT IN THE PATIENT. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19767514 ↗