SMART TSF 71075284Recalls & reported problems
Smith & Nephew, Inc. · SMART TSF WIRE COMBI BOLT (5) · Class 2 · 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 20885556746022), received between Mar 7, 2024 and Feb 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Mechanical Jam1
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 13, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING EXTERNAL FIXATION SURGERY, THREE (3) SMART TSF WIRE COMBI BOLTS SHEARED AND BROKE AT THE NUT. THE PROCEDURE WAS RESUMED, WITHOUT AFTER A DELAY GREATER THAN 30 MINUTES USING A S+N BACK UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21375078 ↗MalfunctionMar 7, 2024Fracture; Mechanical Jam; Fracture; Mechanical Jam
IT WAS REPORTED THAT, DURING TSF REMOVAL, NINE (9) SMART TSF WIRE FIXATION BOLTS SNAPPED INTO TWO PARTS WHILE THE SURGEON WAS TRYING TO MOVE WIRES ON THE FOOTPLATE. IT SEEMS THE 10MM NUTS AND THE BOLTS ARE FUSED SOMEHOW. SOME OF THE NUTS BROKE AND WERE DISCARDED. REMOVAL SURGERY WAS COMPLETED AFTER A DELAY GREATER THAN 30 MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18855966 ↗
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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