ELITE 72202065Recalls & reported problems
Smith & Nephew, Inc. · PREMIUM OPEN FACE SLIDING SUTURE CUTTER, LOOP HANDLE, SIDE LOADING · Class 1
All models of ELITE (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010610249), received between Aug 9, 2021 and Feb 9, 2025 — classified as 1 injury, 2 malfunctions.
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 Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2025Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN USING THE OPEN SUTURE CUTTER, THE TIP OF THE INSTRUMENT BROKE OFF .THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341266 ↗MalfunctionFeb 9, 2025Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN CUTTING THE SUTURE, WHEN THE SUTURE CUTTER LOOP WAS FIRED, IT BROKE INSIDE. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341198 ↗InjuryAug 9, 2021Break; Break
IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR, INSIDE THE PATIENT, THE OPEN SUTURE CUTTER LOOP HANDLE BROKE. ALL PIECES WERE REMOVED FROM THE PATIENT WITH SLOWLY BACKED INTO CANNULA AND REMOVED CANNULA. TAILLESS SUTURE CUTTER WAS USED TO COMPLETED THE PROCEDURE. IT IS UNKNOWN WHEN THE INCIDENT OCCURRED, IF OCCURRED A SURGICAL DELAY AND HOW THE PROCEDURE WAS FINISHED. PATIENT INJURIES WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12298193 ↗
Other ACCESSORIES,ARTHROSCOPIC devices
- Arthrex® AR-12990Arthrex, Inc. · Accessories, arthroscopic409 reports
- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- 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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