ELITE 7209157Recalls & reported problems
Smith & Nephew, Inc. · ELITE CUFF STITCH SUTURE RELAY, 70 DEGREE, RIGHT · Class 1
All models of ELITE (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010448880), received between Sep 4, 2020 and Dec 23, 2024 — classified as 1 injury, 1 malfunction.
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. 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
- Break1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2024Break; Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE, AFTER USING THE OSTEORAPTOR ANCHOR, THE DOCTOR WAS GOING TO USE THE FORCEPS TO HELP WITH THE STITCH AND FINISH, BUT THE CUFF STITCH FORCEPS BROKE IN FRAGMENTS. THE BROKEN FORCEPS WERE REMOVED USING A GRASPER FORCEPS. THE SURGEON FINISHED WITH ANOTHER 'BIRDBUCK' FORCEPS, AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000232 ↗InjurySep 4, 2020Material Separation; Material Separation
IT WAS REPORTED THAT DURING SURGERY THE STITCH OF THE CUFF STITCH CRACKED. PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE, IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS 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 10497083 ↗
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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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