Persona® 42-5399-052-85Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304809093), received between Dec 17, 2019 and Nov 5, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO DRILL A PILOT HOLE THROUGH THE CUT GUIDE. THE DRILL BIT APPEARED TO HAVE COLD-WELDED TO THE CUT GUIDE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10793372 ↗
• MalfunctionOct 23, 2020Mechanical Jam; Mechanical Jam

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 10726566 ↗
• MalfunctionDec 17, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, A DRILL PIN WAS CROSS-THREADED IN A CUT GUIDE AND BECAME STUCK. IT COULD NOT BE REMOVED FROM THE CUTTING BLOCK. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9481243 ↗