Speed SE-1312Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810633022016), received between Jan 30, 2019 and Aug 22, 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 18, 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.

• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD AN INFECTION AND REQUIRED THE NITINOL STAPLES TO BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SPEED 13X12X12MM IMPLANT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17596482 ↗
• MalfunctionSep 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS IMPLANTING A BME SPEED SE-1312 IN A TRIPLE ARTHRODESIS CASE. THE CORRECT DRILL AND DRILL KIT WERE USED WITH THE CORRECT DRILL GUIDE. WHILE PLACING THE SPEED IMPLANT INTO THE DRILLED HOLES, THE STAPLE RELEASED FROM THE INSERTER AND FELL TO THE FLOOR. THE SURGEON STATES THAT THEY DID NOT TRIGGER THE RELEASE BUTTON AND THE STAPLE FELL FREE WITH VERY LITTLE PRESSURE. THERE WERE TWO MINUTES OF SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED AND THERE WAS NO ADVERSE PATIENT IMPACT. THIS REPORT IS FOR A SPEED 13X12X12MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15355413 ↗
• 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) BME SPEED(TM) IMPLANT KIT 13 X 12 MM. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401897 ↗
• MalfunctionJan 30, 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 AN UNKNOWN DATE, THE THEATER STAFF WERE PREPARING AND CHECKING IMPLANTS BEFORE USE AND NOTICED THAT THE SPEED COMPRESSION IMPLANT KIT STAPLE WAS MOVING AROUND FREELY IN ONE IMPLANT. WHEN LOOKING IN TO SEE THROUGH THE PACKAGE, IT WAS NOT ATTACHED TO THE INSERTER. THE PACKAGE HAS NOT BEEN OPENED AND WAS NOT TAMPERED WITH. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: INSERTER: (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1) THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 13X12X12MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8289154 ↗