Speed SE-1108Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810633021996), received between Oct 25, 2021 and Aug 15, 2024 — classified as 1 injury, 2 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.

• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE COMPRESSIVE FORCE OF THE STAPLE IMPLANT CAUSED AN IATROGENIC FRACTURE OF THE PATIENT'S BIG TOE. IT WAS QUESTIONED WHETHER POOR BONE QUALITY, DRILLING TECHNIQUE, OR THE IMPLANT WAS THE CAUSE OF THE IATROGENIC FRACTURE. THE SURGEON ELECTED TO REMOVE THE STAPLE AND USED A K-WIRE FOR FIXATION INSTEAD. THE PROCEDURE WAS COMPLETED WITH A FIFTEEN MINUTE DELAY. THIS REPORT IS FOR A SPEED 11X8X8MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 19995838 ↗
• MalfunctionOct 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE STAPLE ITSELF HAS BROKEN AWAY FROM THE HOLD IT SITS IN WITHIN THE HANDLE ¿ THE STAPLE SHOULD NOT MOVE FROM THE LOADED HANDLE UNTIL THE TRIANGULAR RELEASE BUTTON IS PRESSED WITH FORCE WHEN IN THE PATIENT. PATIENT IMPACT ¿ NONE AS WAS NOT USED IN SURGERY. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 11X08X08MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605653 ↗
• MalfunctionOct 25, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING THE PROCEDURE, THE SPEED COMPRESSION IMPLANT AND UNKNOWN INSERTER WERE UNABLE TO BE RELEASED FROM ONE ANOTHER. WHILE TRYING TO GET THE INSTRUMENT AND IMPLANT TO DISASSEMBLE, THE SURGEON BROKE THE CORTEX OF THE FUSION SITE. THE IMPLANT WAS REMOVED FROM THE BONE WHILE ATTACHED TO THE INSERTER. DURING REMOVAL OF THE IMPLANT, THE INSERTER WAS BROKEN IN HALF. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR (1) SPEED COMPRESSION IMPLANT KIT 11X08X08MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693570 ↗