GREAT WHITE, EXTRASHARP S9399ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854605677), received between May 11, 2022 and May 11, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (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.

• InjuryMay 11, 2022Defective Device; Defective Device

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE, S9399A, 3.5 MM GREAT WHITE STEALTH DEVICE WAS BEING USED ON (B)(6) 2022 DURING A KNEE ARTHROSCOPY PROCEDURE AND ¿ONE OF THE TEETH WAS MADE INCORRECTLY AND POINTED IN THE WRONG DIRECTION, THIS CAUSED THE TOOTH TO SCRATCH ON THE CARTILAGE. THE CARTILAGE WAS DAMAGED ON THE CONDYLE DUE TO THE DEFECT ON THE SHAVER BLADE.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THERE WAS A 10 MINUTE DELAY TO THE PROCEDURE. AFTER FURTHER ASSESSMENT IT WAS FOUND ¿THE DEVICE WAS INSPECTED BEFORE USE, BUT THIS WAS NOT SEEN THEN, BECAUSE THE TEETH ARE SO SMALL.¿ THERE WAS A TEAR ON THE CARTILAGE ON THE TIBIA IN THE KNEE THAT DOES NOT NEED TO BE FIXED. THE CURRENT STATUS OF THE PATIENT IS GOOD. THERE WAS NO EXTENDED STAY AT THE HOSPITAL FOR THE PATIENT AND NO MEDICAL/SURGICAL INTERVENTION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO TEAR TO THE TIBIA.

  Patient problems: Laceration(s)

  MAUDE report 14355294 ↗