NA 2296003511Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 04546540046673), received between Aug 19, 2019 and Jul 22, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Fracture” (38 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25907809 ↗
• MalfunctionMay 14, 2026

  MD NOTICED THE BLADE FOR THE CORE DRILL WAS NOT WORKING CORRECTLY. HE REMOVED THE BLADE FROM THE CORE DRILL, AND IT BROKE INTO THREE PIECES ON THE SIDE OF THE STERILE FIELD NEXT TO PATIENT. ALL THREE PIECES COLLECTED. CTL [CLINICAL TEAM LEAD] AND CHARGE NURSE NOTIFIED. X-RAYS TAKEN IN ROOM BEFORE CLOSING. X-RAY SAID IT WAS OK FOR SURGEON TO READ X-RAYS IN ROOM; RADIOLOGIST TO CONFIRM FINDINGS. NO METAL DETECTED IN PATIENT'S FOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25168504 ↗
• 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 JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 7 EVENTS FOR THE FAILURE: FRACTURE. 7 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399962 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: FRACTURE. 4 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647070 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876044 ↗
• MalfunctionJan 21, 2025Fracture; 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 21200296 ↗
• MalfunctionOct 21, 2024Fracture; 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 20500666 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816041 ↗
• MalfunctionApr 15, 2024Fracture; 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 19113343 ↗
• MalfunctionJan 30, 2024Fracture; 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 18607449 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE IN 3 PLACES. 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 16382426 ↗
• MalfunctionFeb 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THERE WAS A BRIEF DELAY TO OBTAIN A REPLACEMENT BLADE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559632 ↗
• MalfunctionFeb 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THERE WAS A BRIEF DELAY TO OBTAIN A REPLACEMENT BLADE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13526119 ↗
• MalfunctionJan 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT ) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13255969 ↗
• MalfunctionJan 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT ) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13253516 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT ) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13225431 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT ) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13225382 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13225371 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13225286 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT ) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13225209 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT ) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13225165 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT ) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13225164 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT ) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13225162 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT ) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13225158 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT ) SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO REPLACE THE 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 13225073 ↗