STERLING CUDA C9951ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854021729), received between Jul 28, 2025 and Jul 28, 2025 — classified as 1 injury.

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

• InjuryJul 28, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, C9951A, STERLING CUDA SHAVER BLADE, 2.0 MM, WAS BEING USED DURING A RIGHT WRIST ARTHROSCOPY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿TWO SHAVERS BOTH LOT LOT#1415418 BROKE OFF DURING A CASE, AND A PART OF THE TIP WAS NOT RECOVERED FROM THE PATIENT. THE CASE WAS DELAYED 10 MINUTES.¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE USER. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE CAUSING A 10-MINUTE DELAY. THE PATIENT WAS REPORTED AS DISCHARGED HOME. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FRAGMENTATION REMAINING IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22628726 ↗