Speed Triad SE-181508TRCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810633021613), received between Jun 2, 2016 and May 2, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT THE INSERTER HANDLE BROKE AS THE TRIAD IMPLANT WAS BEING INSERTED ON (B)(6) 2019. FRAGMENTS WERE GENERATED BUT EASILY REMOVED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM. PATIENT OUTCOME REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) SPEEDTRIAD COMPRESSION IMPLANT KIT 18X15X8MM CENTERED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573999 ↗
• MalfunctionMar 13, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A DECOMPRESSION OF FIRST METATARSAL (MET) PROCEDURE, THE SURGEON NOTICED THAT THE IMPLANT LEGS SEEMED COMPRESSED. HE LOOKED AT THE HANDLE AND NOTED THAT THE SLIDE ON THE INSERTER WAS HALF WAY PULLED BACK. THE SURGEON TRIED TO IMPLANT THE DEVICE COMPRESSED BY PULLING IT APART BUT COULD NOT GET IT TO THE WORK. HE USED ANOTHER SPEED IMPLANT TO FINISH THE CASE. THERE WERE NO FRAGMENTS GENERATED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DELAY OF 10 MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8418783 ↗
• MalfunctionJun 2, 2016Break; Break

  ONE TRIAD IMPLANT (SE-181508TRC) WAS INSERTED ON UNKNOWN DATE. ON (B)(6) 2015, BROKEN IMPLANT WAS REMOVED, IT WAS RETURNED TO MANUFACTURER ON UNKNOWN DATE. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Information

  MAUDE report 5694923 ↗