NA 6003-300-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540502094), received between Aug 24, 2018 and Jan 21, 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2025Fracture; 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 21200274 ↗
• MalfunctionSep 19, 2019Corroded; Material Disintegration; Corroded; Material Disintegration

  IT WAS REPORTED THAT RUST WAS PRESENT IN THE CUTTING SLOT OF THE DEVICE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING PRIOR TO A MEDICAL PROCEDURE AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9086470 ↗
• MalfunctionAug 1, 2019Break; Break

  IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY THE MANUFACTURER, THE DEVICE WAS FOUND TO HAVE DISASSEMBLED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT WAS FOUND DURING TESTING AT THE MANUFACTURER FACILITY AND THE COMPONENT WAS STILL PRESENT, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851039 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT AT THE USER FACILITY WITH THE METAL SCREW BROKEN. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT WAS DISCOVERED DURING STERILE PROCESSING, THERE WAS NO KNOWN PATIENT INVOLVEMENT AND NO KNOWN DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245958 ↗
• MalfunctionAug 24, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS FOUND IN THE STERILE PROCESSING DEPARTMENT AT THE USER FACILITY WITH THE HEAD OF THE DEVICE BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT WAS DISCOVERED DURING STERILE PROCESSING, THERE WAS NO KNOWN PATIENT INVOLVEMENT AND NO KNOWN DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7812665 ↗