STERLING CUDA C9253Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10845854012543), received between Sep 4, 2018 and Aug 15, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE C9253, 3.5 MM STERLING, CUDA SHAVER BLADE, 6 EA LOT NUMBER 1229881 WAS BEING USED DURING A MENISCUS REPAIR PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿IT BROKE OFF FROM THE TIP OF THE BLADE. IT DIDN'T APPLY EXCESSIVE FORCE, BUT IT BROKE EASILY. THE DETAILS ARE UNKNOWN BECAUSE THERE WAS NO SALES PERSON PRESENT, BUT THE TEACHER SAID THAT IT BROKE EASILY, SO HE WANTED US TO CHECK IF IT WAS A MANUFACTURING DEFECT. (CONFIRMATION OF THE POSSIBILITY OF MANUFACTURING DEFECTS AND THE EXISTENCE OF SIMILAR EVENTS, ETC. FOR THE TWO LOT PRODUCTS THAT MAY BE THE RELEVANT LOT) DOCTOR'S OPINION: ALTHOUGH EXCESSIVE FORCE WAS NOT APPLIED, IT BROKE EASILY, SO PLEASE REPORT WHETHER THERE WERE ANY PROBLEMS WITH THE PRODUCT.¿ FURTHER ASSESSMENT QUESTIONING CONFIRMED THAT THE DEVICE DID FRAGMENT, AND IT WAS REMOVED FROM THE PATIENT¿S BODY.¿ THE PROCEDURE WAS COMPLETED WITH THE SAME ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿THERE IS NO ADDITIONAL REPORT REGARDING THE PATIENT UNTIL TODAY¿. THIS REPORT WILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553075 ↗
• MalfunctionAug 15, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE C9253, 3.5 MM STERLING, CUDA SHAVER BLADE, 6 EA LOT NUMBER 1248683 WAS BEING USED DURING A MENISCUS REPAIR PROCEDURE ON 04JUL23 WHEN IT WAS REPORTED ¿IT BROKE OFF FROM THE TIP OF THE BLADE. IT DIDN'T APPLY EXCESSIVE FORCE, BUT IT BROKE EASILY. THE DETAILS ARE UNKNOWN BECAUSE THERE WAS NO SALES PERSON PRESENT, BUT THE TEACHER SAID THAT IT BROKE EASILY, SO HE WANTED US TO CHECK IF IT WAS A MANUFACTURING DEFECT. (CONFIRMATION OF THE POSSIBILITY OF MANUFACTURING DEFECTS AND THE EXISTENCE OF SIMILAR EVENTS, ETC. FOR THE TWO LOT PRODUCTS THAT MAY BE THE RELEVANT LOT) DOCTOR'S OPINION: ALTHOUGH EXCESSIVE FORCE WAS NOT APPLIED, IT BROKE EASILY, SO PLEASE REPORT WHETHER THERE WERE ANY PROBLEMS WITH THE PRODUCT.¿. FURTHER ASSESSMENT QUESTIONING CONFIRMED THAT THE DEVICE DID FRAGMENT, AND IT WAS REMOVED FROM THE PATIENT¿S BODY.¿. THE PROCEDURE WAS COMPLETED WITH THE SAME ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿THERE IS NO ADDITIONAL REPORT REGARDING THE PATIENT UNTIL TODAY¿. THIS REPORT WILL RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553074 ↗
• MalfunctionSep 4, 2018Fracture; Fracture

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE C9253, 3.5 MM STERLING CUDA 6 EA, DEVICE "FRACTURED AT THE PROXIMAL SIDE" DURING A UNKNOWN TYPE OF SURGERY ON (B)(6) 2018. THE EVENT CAUSED A 0-15-MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORT OF INJURY TO THE USER OR PATIENT. THERE WERE NO FRAGMENTS OR COMPONENTS LOST IN THE SURGICAL SITE; THEREFORE, THERE WAS NOTHING TO RETRIEVE. THERE WAS NO REPORT OF EXTENDED HOSPITAL STAY OR MEDICAL INTERVENTION REQUIRED FOR THE PATIENT. NO OTHER REQUESTED INFORMATION WAS AVAILABLE PER THE REPORTER. 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 7843771 ↗