NA 03.430.502Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982339492), received between Apr 25, 2025 and Sep 23, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Integrity Problem

  It was reported that the blades on the plate cutter are damaged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872326 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT BROKEN INSTRUMENTS. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544759 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT THE FILE HAD COME OFF THE PLATE BENDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159865 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE IN 2025. SURGEON WENT TO CUT THE PLATE AND THE FILE FELL OFF OF THE CUTTER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292768 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THE BURR USED TO SOFTEN EDGES OF PLATES ONCE CUT, CAME OFF. THIS DIDN'T HAPPEN DURING USE. WHEN THE SCRUB PICKED UP THE CUTTER, THE BURR CAME OFF. NO PATIENT HARM, NO ADVERSE EFFECTS AND NO DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278861 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THE PLATE CUTTER RASP CAME OFF. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116620 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, FILING ITEM CAME OFF OF CUTTER. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070718 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, FILING ITEM CAME OFF OF CUTTER. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070628 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 NEW INSTRUMENT CAME APART. THE EVENT OCCUR DURING STERILE PROCESSING. THE EVENT OCCUR DURING FIELD INSPECTION. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056300 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT USER UNWRAPPED THE TRAY TO RESTOCK IT WITH IMPLANTS AND NOTICED THE FILE HAD DELAMINATED FROM THE CUTTER. THIS INSTRUMENT HAD BEEN USED IN SURGERY LESS THAN FIVE TIMES. IT APPEARED TO BE A MANUFACTURING DEFECT AND THE GLUE USED DID NOT HOLD. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936593 ↗
• MalfunctionApr 25, 2025Material Deformation; Material Twisted/Bent; Scratched Material; Material Deformation; Material Twisted/Bent; Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912654 ↗