NA 0277096281Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 04546540880789), received between Oct 16, 2018 and Jul 29, 2025 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Fracture” (37 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD IMAGING REQUIRED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647069 ↗
• MalfunctionJan 21, 2025Fracture; 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 21200282 ↗
• MalfunctionJul 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818500 ↗
• MalfunctionFeb 14, 2023Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH 0700100000-2023-8001: THAT DURING A PROCEDURE, THE BLADE BROKE IN TWO PIECES. 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 16375401 ↗
• MalfunctionDec 8, 2022Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH (B)(4): THAT DURING A PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION 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 15946002 ↗
• MalfunctionJun 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES 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 14787246 ↗
• MalfunctionApr 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WAS A MINOR DELAY AS A RESULT OF THIS EVENT TO GET A REPLACEMENT BLADE. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14024931 ↗
• MalfunctionMar 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE REPLACEMENT PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES 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 13636834 ↗
• MalfunctionFeb 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BLADES BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604940 ↗
• MalfunctionFeb 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BLADES BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604789 ↗
• MalfunctionJan 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE BROKE AT THE MOUNT DURING A SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS A SHORT DELAY TO OBTAIN A REPLACEMENT BLADE AND THERE WERE NO ADVERSE CONSEQUENCES 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 13314601 ↗
• MalfunctionJan 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE BROKE AT THE MOUNT DURING A SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS A SHORT DELAY TO OBTAIN A REPLACEMENT BLADE AND THERE WERE NO ADVERSE CONSEQUENCES 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 13314597 ↗
• MalfunctionJan 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE BROKE AT THE MOUNT DURING A SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS A SHORT DELAY TO OBTAIN A REPLACEMENT BLADE AND THERE WERE NO ADVERSE CONSEQUENCES 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 13306934 ↗
• MalfunctionDec 21, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A TEN MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056299 ↗
• MalfunctionDec 21, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FIVE TO TEN MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056247 ↗
• MalfunctionDec 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKR (TOTAL KNEE REPLACEMENT) PROCEDURE, TWO BLADES BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A MINOR DELAY TO OBTAIN ANOTHER BLADE AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BLADE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047691 ↗
• MalfunctionDec 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKR (TOTAL KNEE REPLACEMENT) PROCEDURE, TWO BLADES BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A MINOR DELAY TO OBTAIN ANOTHER BLADE AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BLADE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047602 ↗
• MalfunctionJul 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES 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 12188002 ↗
• MalfunctionJul 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES 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 12187999 ↗
• MalfunctionJul 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE REVISION SURGERY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THE BLADE CAME INTO CONTACT WITH A METAL IMPLANT. IT WAS FURTHER REPORTED THAT THE PIECE OF THE BROKEN BLADE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES 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 12142664 ↗
• MalfunctionJun 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE BROKE AT THE MOUNT DURING A TOTAL HIP ARTHROPLASTY. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES 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 12060785 ↗
• MalfunctionFeb 16, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, PIECES BROKE OFF THE BLADE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES 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 11333659 ↗
• MalfunctionAug 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE BROKE DURING A SURGICAL PROCEDURE, WHILE CUTTING THE FEMORAL HEAD. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES 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; No Consequences Or Impact To Patient

  MAUDE report 10414599 ↗
• MalfunctionAug 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT WHILE CUTTING THE FEMORAL HEAD DURING A SURGICAL PROCEDURE, TWO BLADES BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BLADE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10414584 ↗
• MalfunctionAug 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT WHILE CUTTING THE FEMORAL HEAD DURING A SURGICAL PROCEDURE, TWO BLADES BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BLADE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10414572 ↗