STERLING GATOR C9264Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854012819), received between Mar 20, 2019 and Mar 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionMar 20, 2019Break; Break

  ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED AN ISSUE WITH THE 3.5MM STERLING GATOR 6EA, ITEM # C9264, LOT # 955107, THAT OCCURRED DURING A SUBTALAR FUSION PROCEDURE ON (B)(6) 2019. IT WAS REPORTED ONLY THAT THE "SHAVER BLADE BROKE DURING USE IN THE OPERATING ROOM". IT IS INDICATED THAT THERE WAS NO REPORTED IMPACT OR INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW SHAVER WITH A 2-MINUTE DELAY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT HALFWAY THROUGH THE PROCEDURE AFTER SOME MILD RESECTION HAD BEEN PERFORMED, THE SURGEON NOTICED THE BLADE WAS BROKEN OFF INSIDE THE SHEATH AT DISTAL END. THE SHAVER BLADE BROKE AT THE HEAD OF THE INNER CUTTING BLADE. IT WAS CONFIRMED THAT NO PIECE OF THE DEVICE FELL INTO THE SURGICAL SITE OR THE PATIENT. SINCE THE DEVICE BROKE WHILE BEING USED IN A PROCEDURE, 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 8437230 ↗