STERLING CUDA, MICROBLADE C9950Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10845854017548), received between Feb 14, 2019 and Dec 9, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, C9950, STERLING CUDA, MICROBLADE SHAVER, 2.0 MM, WAS BEING USED DURING A WRIST SCOPE PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE TIP OF THE SHAVER BROKE OFF. THE TIP WAS RECOVERED SAFELY AND THEY WERE ABLE TO COMPLETE THE CASE WITH ANOTHER SHAVER. THE BROKEN SHAVER BLADE WAS DISPOSED OF IN THEIR SHARPS CONTAINER.¿. THE PROCEDURE WAS COMPLETED AS PLANNED USING AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION FOR 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 23755838 ↗
• MalfunctionAug 25, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE C9950, STERLING CUDA, MICROBLADE SHAVER, DEVICE WAS BEING USED DURING AN ARTHROSCOPIC PROCEDURE ON 01AUG25 WHEN IT WAS REPORTED WAS REPORTED ¿THE SERRATIONS AT THE FRONT END OF THE DEVICE BROKE DURING THE SURGERY.". FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS REMOVED FROM THE SURGICAL SITE WITH THE USE OF FORCEPS. THE PROCEDURE WAS COMPLETED WITH A 15-MINUTE DELAY AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 22882310 ↗
• MalfunctionAug 25, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE C9950, STERLING CUDA, MICROBLADE SHAVER, DEVICE WAS BEING USED DURING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED WAS REPORTED ¿THE SERRATIONS AT THE FRONT END OF THE DEVICE BROKE DURING THE SURGERY.". FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS REMOVED FROM THE SURGICAL SITE WITH THE USE OF FORCEPS. THE PROCEDURE WAS COMPLETED WITH A 15-MINUTE DELAY AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 22882307 ↗
• MalfunctionNov 17, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C9950, 2.0MM STERLING CUDA, MICROBLADE, QTY 6, WAS BEING USED DURING A HAND ARTHROSCOPY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿THE TIP BROKE OFF UNDER THE WRIST ARTHROSCOPY, WHERE WE SHAVE IN SOFT MATERIAL. HAD TO REMOVE IT INSIDE THE JOINT WITH PLIERS¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED USING AN ALTERNATE C9950 DEVICE. FURTHER ASSESSMENT QUESTIONS FOUND THAT THERE WAS A 10-MINUTE DELAY DUE TO THE EVENT AND THAT THE STATUS OF THE PATIENT IS ¿NORMAL¿. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821697 ↗
• MalfunctionFeb 14, 2019Break; Break

  THE CUSTOMER REPORTED THE C9950, 2.0MM STERLING CUDA SHAVER BLADE, BROKE DURING AN ARTHROSCOPIC HAND PROCEDURE ON (B)(6) 2018. THE TIP BROKE OFF DURING USE AND THE BUR TIP WAS RETRIEVED. THERE WAS NO PATIENT INJURY AND NO REPORTED DELAY. THE SURGERY WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338896 ↗