ULTRABRACE 72205500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556890752), received between Jul 29, 2024 and May 1, 2026 — classified as 1 injury, 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Firing Problem

  IT WAS REPORTED THAT, DURING A JOINT STABILIZATION PROCEDURE, THE Q-FIX OF AN ULTRABRACE KIT HAD AN INCORRECT EXPANSION AFTER INTRODUCING INTO THE BONE CANAL. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN ARTHREX COMPETITOR DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062040 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER ANKLE SURGERY PERFORMED ON (B)(6) 2025 WHERE AN ULTRABRACE KIT WAS USED, THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION LAST WEEK. TUNNELING TO THE ANKLE JOINT WAS NOTED, AND THE BONE SCAN WAS POSITIVE FOR SEPTIC ARTHRITIS/OSTEOMYELITIS. THE PATIENT IS CURRENTLY BEING TREATED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Arthritis; Osteomyelitis

  MAUDE report 21628268 ↗
• MalfunctionJul 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A LATERAL LIGAMENT REPAIR, THE FOOTPRINT MINI ANCHOR OF THE ULTRABACE KIT BROKE WHEN THE SURGEON WAS POUNDING THE ANCHOR IN, IT BROKE IN HALF (HORIZONTALLY) IN THE TRANSVERSE PLANE. IT BROKE AND FLEW ON GROUND. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19856127 ↗