Speed SE-2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810633020227), received between Apr 5, 2016 and Dec 11, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ITEM WAS OPENED WITHIN THEATRE BUT THE STAPLE WAS DISLODGED FROM THE HANDLE. THE ITEM WAS DISPOSED OF AS PER HOSPITAL POLICY. NO TIME ADDED TO THE PROCEDURE. PATIENT DETAILS UNAVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9452632 ↗
• MalfunctionApr 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THE CLAMP OF THE SPEED COMPRESSION IMPLANT KIT HAS RELEASED FROM THE INSTRUMENT INSIDE OF THE STERILE PACKAGING. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8542020 ↗
• MalfunctionFeb 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, WHILE THE SCRUB STAFF WAS PREPARING FOR AN UNKNOWN PROCEDURE, THE STAFF NOTICED THE SPEED COMPRESSION IMPLANT KIT WAS NOT FULLY CONSTRAINED. IT WAS IN AN OPEN POSITION AND PACKAGING WAS VISIBLY INCORRECT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPEED 20 X 20 X 20MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8343708 ↗
• MalfunctionMar 19, 2018Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE TO IMPLANT A SPEED TITAN SE-2020 BONE STAPLE ON (B)(6) 2018, IT WAS NOTED THAT THE HANDLE OF THE DEVICE WAS CRACKED DIRECTLY ABOVE THE RELEASE MECHANISM. THE SURGEON ELECTED TO CONTINUE USING THE DEVICE; HOWEVER, FOUND IT CHALLENGING TO RELEASE THE STAPLE FROM THE INSERTION HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THERE WAS A 30 SECOND DELAY NOTED DUE TO THE DAMAGED DEVICE. NO ADVERSE EVENTS WERE REPORTED AGAINST THE PATIENT. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7349890 ↗
• MalfunctionApr 5, 2016Break; Break

  SPEED (SE-2020) WAS INSERTED APPROPRIATELY DURING TRIPLE PROCEDURE (B)(6) 2013. FOLLOW-UP X-RAY (B)(6) 2014 REVEALED THAT IMPLANT HAD BROKEN. PATIENT HAS NOT REQUIRED REVISION SURGERY, NOR REMOVAL OF BROKEN IMPLANT. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5549384 ↗