NA 45-20004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540534392), received between Aug 20, 2019 and Aug 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2019Break; Detachment of Device or Device Component

  THE NURSE STATED THAT DURING THE OPERATION THE SCREW DRIVER WAS WORKING INITIALLY, THEN IT STOPPED WORKING AND THE SCREW DRIVER WAS FAILING TO CAPTURE THE SCREW. THE NURSE STATED IT WAS THEN NOTICED BY THE SCRUB NURSE THAT THE SCREW DRIVER HEAD FELT 'SHARP', AND THE TIP OF IT APPEARED TO BE BROKEN OFF. THE NURSE STATED THE OPERATING STAFF BECAME CONCERNED THAT THE TIP OF THE SCREW DRIVER MAY HAVE BEEN BROKEN OFF INSIDE THE PATIENT. SUCTION WAS APPLIED TO THE AREA, AND THEN THE TIP OF THE SCREW DRIVER THAT BROKE OFF WAS SUCCESSFULLY RETRIEVED FROM THE SUCTION DEVICE. THE NURSE STATED THAT AN X-RAY WAS THEN PERFORMED OF THE AREA, AND THE SURGEON WAS CONFIDENT THERE WERE NO FOREIGN OBJECTS INSIDE THE PATIENT. AN ALTERNATE SCREW DRIVER WAS USED SUCCESSFULLY. THE BROKEN SCREW DRIVER WITH THE BROKEN PIECE OFF THE END WAS PUT ASIDE. NO ADVERSE CONSEQUENCES WERE REPORTED AND THE PROCEDURE WAS OTHERWISE COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8913068 ↗