ELITE 72202042Recalls & reported problems
Smith & Nephew, Inc. · ELITE SHOULDER ARTHROSCOPY STERILIZATION TRAY AND LID · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010621801), received between Mar 28, 2019 and Mar 1, 2020 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY OR BACK UP AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9772825 ↗MalfunctionMar 28, 2019Break
IT WAS REPORTED THAT THE DRILL BROKE INSIDE THE FEMORAL TUNNEL. FRAGMENTS WERE TOTALLY REMOVED. IT IS UNKNOWN IF THERE WAS DELAY OR IF A BACK UP DEVICE WAS USED. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8462388 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.