LANZA 9391MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854850404), received between Jan 30, 2020 and Jun 25, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2020Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 9391M WAS BEING USED ON (B)(6) 2020 DURING A KNEE ARTHROSCOPY PROCEDURE WHEN THE TIP OF THE BLADE BROKE OFF WHEN TRYING TO RESECT MENISCAL TISSUE. A GRASPER WAS USED TO REMOVE THE COMPONENT OF THE DEVICE FROM THE PATIENT. THIS CAUSED A 20-MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO INJURY TO THE PATIENT/USER, NO MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION. THE PATIENT IS REPORTED AS RECOVERING. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194518 ↗
• MalfunctionJan 30, 2020Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED AN ISSUE WITH AN 9391M, 4.2MM X 13CM 15 DEGREE LANZA, LOT # 1036186 THAT OCCURRED AT (B)(6) ON (B)(6) 2020. IT WAS REPORTED THAT THE TIP BROKE IN THE PATIENT. THEY NOTED THAT NO BONE WAS HIT WHEN THE TIP BROKE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE AND FINISH THE CASE. NO OTHER BLADES WERE OPENED TO FINISH THE CASE. ADDITIONAL INFORMATION OBTAINED INDICATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE KNEE ARTHROSCOPY PROCEDURE WAS SUCCESSFULLY COMPLETED USING A CURVED GREAT WHITE 4.2 BLADE THE SURGEON WAS PREVIOUSLY USING. THE DEVICE IN QUESTION HAD BEEN USED FOR SEVERAL MINUTES WHEN IT WAS DISCOVERED THE FRAGMENT IN THE KNEE. THERE WAS A DELAY WHILE TRYING TO RETRIEVE SHAVER FRAGMENT, BUT THE EXACT LENGTH OF TIME IS UNKNOWN. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE (FRAGMENTATION FALLING IN THE PATIENT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649318 ↗