Speed Triad SE-201508TRCRecalls & reported problems
Synthes GmbH · Speed Triad 20X15X08mm 3 Legs, centered · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810633021644), received between Mar 2, 2021 and Mar 2, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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 18, 2026.
Most reported problems
Device problems
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2021Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON OPENING BME SPEED STAPLE, IT WAS DISCOVERED THAT THE STAPLES WERE ALREADY COMPRESSED, SO WE WENT TO TRY A DIFFERENT ONE AND THE SAME THING HAPPENED WITH 3 STAPLE IMPLANT KITS. BILATERAL BUNION CORRECTIONS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES 3 DEVICES. THIS REPORT IS FOR (1) SPEEDTRIAD(TM) IMPLANT KIT 20 X 15 X 8 MM, CENTERED. THIS REPORT IS 3 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11401861 ↗
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- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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