STERLING GATOR C9960ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854012789), received between Jan 22, 2025 and Oct 27, 2025 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C9960A, STERLING GATOR SHAVER BLADE, 2.0 MM WAS BEING USED ON (B)(6) 2025 AND ¿WE HAD A GATOR SHAVER(REF: (B)(4)/LOT: 1436294) BREAK INSIDE A PATIENT... LOOSE PIECES WERE RETRIEVED AND I AM SENDING THEM IN ALONG WITH THE REST OF THE PART.¿ THE SURGEON CLIPPED THE SHAVER WITH THE CAMERA. THERE WAS NO IMPACT OR INJURY TO 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 23392554 ↗
• InjuryJan 22, 2025Break; Break

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, C9960A, STERLING GATOR SHAVER BLADE, 2.0 MM, WAS BEING USED DURING A WRIST SCOPE PROCEDURE ON (B)(6)2025 WHEN IT WAS REPORTED, ¿SHAVER BLADE BROKE OFF IN THE JOINT DURING ARTHROSCOPIC SHAVING.¿. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED. FURTHER ASSESSMENT QUESTIONING WAS SENT TO THE REPORTER; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF BLADE BROKEN IN WRIST AND WITH POSSIBLE FRAGMENTATION RETAINED IN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21206668 ↗