ELITE 72201213Recalls & reported problems
Smith & Nephew, Inc. · ELITE PREMIUM FULL LOOP KNOT MANIPULATOR, SILVER HANDLE 2 PER BOX · Class 1
All models of ELITE (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010591272), received between Oct 9, 2017 and May 3, 2019 — classified as 4 malfunctions.
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.
Most reported problems
Device problems
- Break2
- Device Operates Differently Than Expected2
- Cut In Material1
Patient problems
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2019Break
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, WHEN KNOTTING, THE KNOT MANIPULATOR CUT THE ULTRATAPE SUTURE. THE SUTURE WAS REMOVED FROM THE BODY. AFTER SUTURE BREAKAGE, THE IMPLANT WAS RE-SECURED WITH THE BACK-UP ULTRA TAPE DEVICE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH EXTENDED SURGICAL TIME OF 15 MIN. THE PATIENT WAS NOT INJURED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8578495 ↗MalfunctionJun 27, 2018Cut In Material
IT WAS REPORTED THAT THE KNOT MANIPULATORS CUT THE ULTRABRAID #2 SUTURE DURING THE KNOTTING. NO SIGNIFICANT DELAY OR PATIENT INJURY WERE REPORTED. A BACK UP WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7642100 ↗MalfunctionDec 4, 2017Break; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE KNOT PUSHER SEEMS TO HAVE A BURR AND CUT THE SUTURE. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7080625 ↗MalfunctionOct 9, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE KNOT PUSHER CUT THE SUTURE WHILE KNOTTING IT. A BACK-UP DEVICE WAS AVAILABLE AND THERE WAS NO DELAY DURING SURGERY. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6931095 ↗
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- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- 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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