NA 2296003114Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540046505), received between Jan 18, 2019 and Oct 28, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025 ¿ (B)(6) 2025. 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 23399848 ↗
• MalfunctionMar 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, 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 16598293 ↗
• MalfunctionAug 19, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE MOUNT OF THE BLADE BROKE IN THREE BLADES USED. 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. THIS RECORD RELATES TO ONE OF THE THREE BLADES WHICH BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8906127 ↗
• MalfunctionJan 18, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO SAW BLADES BROKE. IT WAS ALSO REPORTED THAT THE BLADE WAS MOUNTED ON THE STRYKER CORE MOTOR HANDPIECE. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR IS RELATED TO THE FIRST BLADE THAT BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8261740 ↗
• MalfunctionJan 18, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO SAW BLADES BROKE. IT WAS ALSO REPORTED THAT THE BLADE WAS MOUNTED ON THE STRYKER CORE MOTOR HANDPIECE. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR IS RELATED TO THE SECOND BLADE THAT BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8261737 ↗