Speed SE-1110Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00810633020128), received between Feb 12, 2016 and Mar 2, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY TO REMOVE A STAPLE FROM A PREVIOUS FOOT SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 24486578 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE USING A BME SPEED CCI (SE-1110) THE STAPLE CAME OFF THE INSERTER BEFORE PUSHING ON THE DEPLOY TAB ON THE INSERTION HANDLE. THERE WAS SURGICAL DELAY OF TWO MINUTES. IT IS UNKNOWN IF THE SURGERY WAS SUCCESSFULLY COMPLETED OR NOT. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 11X10X10MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171169 ↗
• MalfunctionApr 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE SURGEON ATTEMPTED TO USE THE BME SPEED IMPLANT AND THE IMPLANT DEPLOYED (OR WAS ALREADY DEPLOYED) BEFORE THE SURGEON INITIATED DEPLOYMENT. THE IMPLANT WAS UNABLE TO BE USED PRIOR TO INTERACTING WITH THE PATIENT DIRECTLY. A NEW BME SPEED IMPLANT WAS OPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THREE MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SPEED 11 X 10 X 10MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700580 ↗
• MalfunctionJul 12, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ON MAY 20, 2022, UPON ORGANIZING BME STAPLES IN PREPARATION FOR SURGEONS' SCAPHOCAPITATE FUSION CASE, IT WAS DISCOVERED THAT ONE OF THE BME SPEED IMPLANTS HAD DEPLOYED INSIDE OF ITS PACKAGING, SEALS STILL INTACT. THIS IMPLANT WAS NOT NEEDED DURING THE CASE. THERE WAS NO PATIENT CONSEQUENCES. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A SPEED COMPRESSION IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986178 ↗
• MalfunctionMar 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2022 DURING AN UNKNOWN PROCEDURE ITEM SE-1110 WAS RENDERED DEFECTIVE BY THE SURGEON WHEN ATTEMPTING TO IMPLANT. THE ITEM WAS DISCARDED AND AN ADDITIONAL SE-1110 WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13901041 ↗
• MalfunctionJan 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPEED COMPRESSION IMPLANT KIT RELEASED EARLY FROM INSERTION HANDLE. THERE IS NO SURGICAL DELAY REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 11X10X10MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155066 ↗
• MalfunctionNov 6, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, IT WAS OBSERVED THAT THE BME SPEED IMPLANT KIT WAS DISENGAGED FROM INSERTER INSIDE THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) BME SPEED(TM) IMPLANT KIT 11 X 10 MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10804708 ↗
• MalfunctionSep 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UPDATED: THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE IMPLANT. ONCE IT WAS INSERTED INTO THE PATIENT THE DEVICE CAME OFF THE INSERTER ON ITS OWN. THE SURGEON WAS ABLE TO SALVAGE IT AND PRESS IT INTO PLACE WITH PRESSURE. CONCOMITANT DEVICES REPORTED: SPEED COMPRESSION IMPLANT SIZING GUIDE (PART #: SG-1, LOT #: BSG180969, QUANTITY: 1), SPEED DRILL KIT (PART #: DK-200, LOT #: BDK200042, QUANTITY: 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10587447 ↗
• MalfunctionSep 15, 2020Detachment 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 A SPEED STAPLE DISENGAGED PREMATURELY BEFORE SURGEON PRESSED THE BUTTON (DURING INSERTION) DURING A PROCEDURE ON (B)(6) 2020. THE DISLODGEMENT OF THE CCI CAUSED A 30 MINUTE DELAY IN THE OPERATION. THEY WERE UNABLE TO GET THE CCI PROPERLY RE-LOADED ONTO THE INSERTER, BUT WERE ABLE TO USE VARIOUS INSTRUMENTS TO SEAT EACH IMPLANT LEG INTO THE PRE-DRILLED HOLES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535323 ↗
• MalfunctionMar 20, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, NEITHER OF THE TWO (2) SPEED COMPRESSION PLATE, ONE (1) SPEED COMPRESSION IMPLANT SIZING GUIDE, ONE (1) SPEED DRILL KIT AFTER THEY WERE DEPLOYED FROM THE INSERTER THE LEGS STAYED STRAIGHT AND DID NOT COMPRESS AT ALL. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861419 ↗
• MalfunctionMar 20, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, NEITHER OF THE TWO (2) SPEED COMPRESSION PLATE, ONE (1) SPEED COMPRESSION IMPLANT SIZING GUIDE, ONE (1) SPEED DRILL KIT AFTER THEY WERE DEPLOYED FROM THE INSERTER THE LEGS STAYED STRAIGHT AND DID NOT COMPRESS AT ALL. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861412 ↗
• MalfunctionNov 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, IN ONE OF THEIR TOTS, IT WAS NOTICED THAT IN THE PACKAGED, THE SPEED COMPRESSION IMPLANT KIT WAS ACTUALLY ALREADY BEEN DEPLOYED IN THE PACKAGING. SO, IT LOOKS LIKE SOME KIND OF A BAD STAPLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 OF 1 FOR (B)(4). .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9267552 ↗
• MalfunctionAug 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING THE IMPLANTATION OF THE STAPLE, IT WAS OBSERVED THAT THE PLASTIC INSERTER WAS DEFECTIVE AND THE STAPLE FELL OFF THE INSERTER DURING INSERTION. SURGEON ATTEMPTED TO PUT IT BACK ON THE STAPLE INSERTER, BUT A NEW PACKAGE WAS OPENED. THERE WAS A SURGICAL DELAY OF A COUPLE OF MINUTES. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 11 X 10 X 10 MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8860986 ↗
• MalfunctionMay 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A FOOT SURGERY PROCEDURE, THE SPEED COMPRESSION IMPLANT KIT WAS DISLODGED FROM THE INSERTER DURING TRANSFER TO THE STERILE FIELD. IT WAS REPLACED WITH ANOTHER SPEED COMPRESSION IMPLANT KIT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. 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 8632781 ↗
• MalfunctionMar 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGICAL DELAY IS UNKNOWN. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8401339 ↗
• MalfunctionDec 1, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A MTP FUSION ON (B)(6) 2017, WHEN INSERTING THE STAPLE, ONE OF THE LEGS DID NOT SEAT COMPLETELY DUE TO A PREVIOUSLY IMPLANTED COMPETITOR¿S SCREW. SUBSEQUENTLY, THE SURGEON TOOK THE STAPLE OUT AND WENT TO RE-LOAD IT ONTO THE HANDLE, AND THE HANDLE CAME APART (WHICH IT IS SUPPOSED TO DO). THERE WAS A REPORTED SURGICAL DELAY OF FIVE MINUTES DUE TO THE SURGEON RE-INSERTING THE IMPLANT WITHOUT THE HANDLE. THIS COULD HAVE BEEN CAUSED BY A DRILLING ERROR ¿ THE PREVIOUSLY INSERTED SCREW CAUSED A LIMITED AREA FOR DRILLING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7076584 ↗
• MalfunctionFeb 12, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT HALLUX IPJ FUSION PROCEDURE FOR GREAT LEFT TOE ON (B)(6) 2015 AND TWO SPEED DEVICES (SIZES 09-07 AND 11-10) WERE IMPLANTED. AT FOUR MONTHS POST OPERATIVE, IT WAS NOTED DURING FOLLOW-UP APPOINTMENT THAT STAPLES WERE "BACKING OUT". DEVICES WERE EXPLANTED ON (B)(6) 2016.

  Patient problems: No Code Available

  MAUDE report 5435679 ↗