PiGalileo / TC-PLUS / RT-PLUS 75009340Recalls & reported problems
Smith & Nephew, Inc. · PIGALILEO NAVIGATION PACKAGE SPEED-PINS 3.2 110(6X) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996100549), received between Nov 27, 2019 and Nov 27, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2019Fracture; Fracture
IT WAS REPORTED THAT A PIECE OF AN UNKNOWN DEVICE WAS FOUND INTRAOPERATIVELY. FOUND UNDER X-RAYS AND A PROCEDURE WAS REQUIRED IMMEDIATELY TO RETRIEVE IT. THE PIECE IS APPROXIMATELY 10MM X 4MM. A DELAY LONGER THAN 30 MINUTES WAS REPORTED. NO DEVICE BACKUP REQUIRED.
Patient problems: Injury
MAUDE report 9387514 ↗
Other PIN, FIXATION, SMOOTH devices
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- SMART TOE ST0A-16PStryker GmbH · PIN, FIXATION, SMOOTH1 recall5 reports
- SMART TOE ST0-19PStryker GmbH · PIN, FIXATION, SMOOTH1 recall2 reports
- SMART TOE ST0-22PStryker GmbH · PIN, FIXATION, SMOOTH1 recall0 reports
- SMART TOE ST0XS-11Stryker GmbH · PIN, FIXATION, SMOOTH1 recall0 reports
- HammerTube™ System P40-002-0275-SParagon 28, Inc. · PIN, FIXATION, SMOOTH1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 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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