ENDOBUTTON 7210153Recalls & reported problems
Smith & Nephew, Inc. · ENDOBUTTON CL PAC, CONTAINS LATEX, STERILE · Class 2
All models of ENDOBUTTON (21)
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 00885554012293), received between Jan 11, 2019 and Jan 11, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (4 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
- Failure to Cut4
- Dull, Blunt3
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.
MalfunctionJan 11, 2019Failure to Cut
IT WAS REPORTED THAT DURING AN ACL SURGERY THE DEVICE WAS NOT CUTTING, IT WAS DULL AND DIFFICULT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES REPORTED. THERE WAS A DELAY GREATER THAN 30 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8242191 ↗MalfunctionJan 11, 2019Dull, Blunt; Failure to Cut
IT WAS REPORTED THAT DURING AN ACL SURGERY THE DEVICE WAS NOT CUTTING, IT WAS DULL AND DIFFICULT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES REPORTED. THERE WAS A DELAY GREATER THAN 30 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8242176 ↗MalfunctionJan 11, 2019Dull, Blunt; Failure to Cut
IT WAS REPORTED THAT DURING AN ACL SURGERY THE DEVICE WAS NOT CUTTING, IT WAS DULL AND DIFFICULT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES REPORTED. THERE WAS A DELAY GREATER THAN 30 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8242153 ↗MalfunctionJan 11, 2019Dull, Blunt; Failure to Cut
IT WAS REPORTED THAT DURING AN ACL SURGERY THE DEVICE WAS NOT CUTTING, IT WAS DULL AND DIFFICULT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES REPORTED. THERE WAS A DELAY GREATER THAN 30 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8242119 ↗
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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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