ZUK 00584301800Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556621318), received between Dec 28, 2018 and Oct 8, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2020Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation

  IT WAS REPORTED THAT THE DRILL HAS GOUGES AND IS DULL. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10648515 ↗
• MalfunctionSep 28, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING EFIP INSPECTION PROCESS, WAS NOTICED THAT THE PRECOAT FEMORAL DRILL W/STOP IS DULL AND GOUGED METAL ON SHAFT. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10591587 ↗
• MalfunctionSep 25, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ALL INSTRUMENTS FROM THE SAME SET THAT NEED REPLACING DUE TO WEAR AND TEAR OF USE. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10589720 ↗
• MalfunctionJun 24, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT UPON INSPECTION THE DRILLS WERE FOUND DULL. NO INJURY, NO DELAY, NOTICED AFTER CASE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10192374 ↗
• MalfunctionJun 24, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT UPON INSPECTION THE DRILLS WERE FOUND DULL. NO INJURY, NO DELAY, NOTICED AFTER CASE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10192373 ↗
• MalfunctionDec 28, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING TKA IT WAS NOTICED DRILL WAS DULL AND NEEDED TO BE SHARPENED. NO DELAY, HAD BACKUP, NO INJURY. SURGERY WAS COMPLETED FREEHAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8205061 ↗