ELITE 7209154Recalls & reported problems
Smith & Nephew, Inc. · ELITE CUFF STITCH SUTURE RELAY, 30 DEGREE, LEFT · 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 03596010448842), received between Dec 15, 2022 and Feb 29, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. 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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 29, 2024Break; Break
IT WAS REPORTED THAT DURING THE CUFF INSTABILITY PROCEDURE, THE DOCTOR WAS SUTURING THE SHOULDER USING A CUFF STITCH DEVICE AND WAS HAVING DIFFICULTY BENDING THE PASS. WHEN TRYING TO UNTWIST THE TIP IT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE REPORTED DEVICE. THERE WAS NO SURGICAL DELAY NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18809119 ↗InjuryDec 15, 2022Break; Break
IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE TIP OF A CUFF STITCH SUTURER BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15988966 ↗
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- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- 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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