ZUK 00584305100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556621646), received between Jan 16, 2019 and Jan 16, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 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.

• MalfunctionJan 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY THE FEMORAL DRILL IS DULL, NEEDS EXCESSIVE FORCE TO DRILL IN. THE DRILL WAS THEN STUCK, COULD NOT GET OUT. A DELAY LESS THAN 30 MIN WAS REPORTED. A BACKUP DEVICE WAS NOT AVAILABLE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8254307 ↗