LANZA 9391ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30845854046184), received between Jun 12, 2024 and Aug 12, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 16, 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.

• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219715 ↗
• MalfunctionJun 18, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 9391A, 4.2MM X 13 CM LANZA SHAVER BLADE, 6 EA, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE TIP OF THE SHAVER BLADE CAME APART IN THE PATIENTS KNEE, THE SURGEON WAS ABLE TO RETRIEVE THE TIP OF THE SHAVER BLADE, THEN CONFIRMED IT BY TAKING A LIVE XRAY WITH THE MINI C-ARM. THE SURGERY WAS DELAYED BY ABOUT 20 MINUTES.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559518 ↗
• MalfunctionJun 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 9391A, 4.2MM X 13 CM LANZA 6 EA WAS BEING USED ON 22MAY24 AND ¿THE TIP OF THE OUTER SHEET FELL OFF INSIDE THE PATIENT¿S JOINT. THE SURGEON WAS ABLE TO GET THE PART OUT OF THE JOINT WITH FORCEPS.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF A NEW LANZA BLADE. THERE WAS A 5 MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521074 ↗