XTENDOBUTTON 72200134Recalls & reported problems
Smith & Nephew, Inc. · XTENDOBUTTON FIXATION DEVICE · Class 1 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010565471), received between Apr 9, 2024 and Jul 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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
- Delivered as Unsterile Product2
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem
IT WAS REPORTED THAT, DURING SET UP, THE XTENDOBUTTON FIXATION DEVICE INNER PACKAGING BAG HAD LEAKED AIR, THE STERILE BARRIER WAS COMPROMISED. THERE WAS A BACK-UP DEVICE AVAILABLE, AND THERE WAS A DELAY OF LESS THAN 30 MINUTES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22626958 ↗MalfunctionApr 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE X-ENDOBUTTON SACHET IN WHICH THE IMPLANT WAS PLACED WAS NOT TIGHTLY CLOSED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Perforation
MAUDE report 19076496 ↗
Other RETENTION DEVICE, SUTURE devices
- Q-Stop QSDRS Vascular, Inc. · Retention Device, Suture1 recall0 reports
- XTENDOBUTTON 71935602Smith & Nephew, Inc. · RETENTION DEVICE, SUTURE5 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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