Speed SE-1308Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810633022009), received between Apr 2, 2019 and Feb 17, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2023Difficult to Advance; Mechanical Jam; Difficult to Advance; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS REPORTED THAT THE DOCTOR HAD DIFFICULTY WITH RELEASING THE STAPLE; APPEARED TO REQUIRE A SIGNIFICANT AMOUNT OF FORCE TO RELEASE. DUE TO DIFFICULTY, IT WAS RELEASED OUTSIDE OF DRILL HOLES AND THEREFORE WAS NOT ABLE TO FIT IN DRILLED HOLES RESULTING IN A NEW STAPLE BEING USED. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 13X08X08MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397729 ↗
• MalfunctionApr 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPEED COMPRESSION IMPLANT KIT STAPLE FELL OFF OF THE INSERTER. ANOTHER KIT HAD TO BE OPENED AND USED. THERE WERE TWO (2) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SPEED COMPRESSION IMPLANT KIT 13X08X08MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9917330 ↗
• MalfunctionAug 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, A SPEED COMPRESSION IMPLANT KIT MISFIRED FROM THE HANDLE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: HANDLE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A SPEED COMPRESSION IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874479 ↗
• InjuryApr 2, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2019, THE SPEED COMPRESSION IMPLANT KIT MISFIRED. WHEN HANDLING THE STAPLE ON THE INSERTER HANDLE THE STAPLE FIRED LOOSE PRIOR TO INSERTION. THE SURGEON USED ANOTHER SIZE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO ADVERSE EVENT REPORTED. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 13X08X08MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8474420 ↗