NA 2296003525Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540046680), received between Jan 24, 2023 and Apr 22, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954416 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816068 ↗
• InjuryOct 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE CUTTING OF A PATIENT¿S BONE, THE BLADE BROKE, THIS HAPPENED ON THREE OCCASIONS, (THIS IS FOR EVENT THREE). IT WAS ALSO REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE FRAGMENTS OF BROKEN BLADE. IT WAS FURTHER REPORTED THAT THE MEDICAL INTERVENTION WAS SUCCESSFUL AND DID NOT CAUSE A DELAY, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914450 ↗
• InjuryOct 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE CUTTING OF A PATIENT'S BONE, THE BLADE BROKE, THIS HAPPENED ON THREE OCCASIONS, (THIS IS FOR EVENT ONE). IT WAS ALSO REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE FRAGMENTS OF BROKEN BLADE. IT WAS FURTHER REPORTED THAT THE MEDICAL INTERVENTION WAS SUCCESSFUL AND DID NOT CAUSE A DELAY, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914449 ↗
• InjuryOct 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE CUTTING OF A PATIENT¿S BONE, THE BLADE BROKE, THIS HAPPENED ON THREE OCCASIONS, (THIS IS FOR EVENT TWO). IT WAS ALSO REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE FRAGMENTS OF BROKEN BLADE. IT WAS FURTHER REPORTED THAT THE MEDICAL INTERVENTION WAS SUCCESSFUL AND DID NOT CAUSE A DELAY, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914440 ↗
• MalfunctionMar 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ANKLE BONE OSTEOTOMY PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16476758 ↗
• MalfunctionJan 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION TKA PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237554 ↗