NA 72201180Recalls & reported problems
Smith & Nephew, Inc. · ELITE PREMIUM ALLIGATOR GRASPER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010594440), received between Oct 1, 2020 and Mar 31, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2024Break; Break
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ELITE PREMIUM ALLIGATOR GRASPER BROKE WHEN THE SPECIALIST TRIED TO REMOVE A PLATE FROM THE JOINT WITH IT. SURGERY WAS COMPLETED A COMPETITOR DEVICE FOUND ON THE INSTITUTION. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH CONDITION IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009391 ↗InjuryDec 9, 2020Break; Break
IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, WHEN THE DR. WAS REMOVING AN ANCHOR THAT WAS FROM A PRIOR SURGERY IN THE SHOULDER WITH THE "ELITE PREMIUM ALLIGATOR GRASPER"; IT BROKE AND WAS NOT CLOSING CORRECTLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAYS. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10978061 ↗InjuryOct 1, 2020Break; Break
IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE ALLIGATOR GRASPER'S TOP JAW BROKE OFF AS THE SURGEON WAS TRYING TO RETRIEVE A LOSE BODY FROM THE JOINT. THERE WAS A BACKUP DEVICE AVAILABLE. NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Information
MAUDE report 10617391 ↗
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- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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