NA 0277096325Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 04546540051783), received between Aug 29, 2019 and Apr 22, 2026 — classified as 1 injury, 94 malfunctions.

The most frequently reported specific device problem is “Fracture” (90 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 25 most recent of 95 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 JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954438 ↗
• MalfunctionOct 1, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23188747 ↗
• MalfunctionSep 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE, WITH INCREASED BLOOD LOSS REPORTED OF AN UNKNOWN AMOUNT. IT WAS ALSO REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AND AN INSIGNIFICANT CLINICAL DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23177535 ↗
• 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 5 EVENTS FOR THE FAILURE: FRACTURE - 5 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647047 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 8 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876039 ↗
• 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200288 ↗
• InjuryNov 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE. IT WAS FURTHER REPORTED THAT THE PATIENT SUFFERED A CUT ARTERY, WHICH REQUIRED A BLOOD TRANSFUSION. IT WAS ALSO REPORTED THAT A NEW BLADE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY ISSUES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20590704 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992797 ↗
• MalfunctionJul 26, 2023Fracture; 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 17398840 ↗
• MalfunctionMay 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A RIGHT BELOW KNEE AMPUTATION , 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 16962733 ↗
• MalfunctionApr 24, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801357 ↗
• MalfunctionApr 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THA 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 16719380 ↗
• MalfunctionFeb 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A BELOW KNEE AMPUTATION 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 16316112 ↗
• MalfunctionFeb 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THA 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 16303539 ↗
• MalfunctionJan 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16238000 ↗
• MalfunctionDec 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE AT THE MOUNT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022164 ↗
• MalfunctionDec 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A BKA REVISION, THE BLADE BROKE 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 15946708 ↗
• MalfunctionDec 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A BKA REVISION, THE BLADE BROKE 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 15945974 ↗
• MalfunctionNov 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A 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 15880193 ↗
• MalfunctionNov 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A 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 15868643 ↗
• MalfunctionNov 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO A MEDICAL PROCEDURE, THE CUSTOMER NOTED THAT THE BLADE WAS BROKEN. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742280 ↗
• MalfunctionOct 17, 2022Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH REPORT # (B)(4), THAT DURING A JOINT REPAIR PROCEDURE, THE BLADE BROKE, THE BROKEN FRAGMENT WAS REMOVED. 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 15618186 ↗
• MalfunctionSep 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE AT THE MOUNT. THE BROKEN PIECE OF BLADE WAS UNABLE TO BE REMOVED FROM THE HANDPIECE. 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 15520895 ↗
• MalfunctionSep 20, 2022Fracture; Fracture

  AS PER MEDWATCH REPORT: IT WAS REPORTED THAT DURING AN ABOVE THE KNEE AMPUTATION PROCEDURE, THE BLADE BROKE IN 2 PIECES. 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 15457870 ↗
• MalfunctionSep 20, 2022Fracture; Fracture

  AS PER MEDWATCH REPORT: IT WAS REPORTED THAT DURING AN ABOVE THE KNEE AMPUTATION PROCEDURE, THE BLADE BROKE IN 2 PIECES. 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 15457869 ↗