Speed SE-1310Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00810633020142), received between Aug 26, 2019 and Apr 2, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024 THE STAPLE CAME OFF THE INSERTER BEFORE THE IMPLANT. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE SPEED 13X10X10MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19022715 ↗
• 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 13X10X10MM IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17596485 ↗
• MalfunctionJun 29, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPEED COMPRESSION IMPLANT KIT 13X10X10MM STAPLES WERE BROKE OFF OF THE INSERTER INSIDE OF THE STERILE PACKAGE. IT WAS UNKNOWN WHEN THE EVENT WAS OBSERVED. THERE IS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 13X10X10MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14860424 ↗
• MalfunctionJun 29, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPEED COMPRESSION IMPLANT KIT 13X10X10MM STAPLES WERE BROKE OFF OF THE INSERTER INSIDE OF THE STERILE PACKAGE. IT WAS UNKNOWN WHEN THE EVENT WAS OBSERVED. THERE IS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1)SPEED COMPRESSION IMPLANT KIT 13X10X10MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14860025 ↗
• MalfunctionAug 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, THE STAPLE FELL OFF OF THE INSERTER PRIOR TO INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A STAPLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12357913 ↗
• 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 10 MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401908 ↗
• MalfunctionSep 23, 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 THAT DURING STOCK EXPIRY DATE CHECK IT WAS NOTICED THAT THE MEMORY STAPLE APPEARS TO HAVE DISENGAGED FROM IT'S INSERT WHILE STILL IN THE PACKET. IT CAN NO LONGER BE USED IN AN OPERATION. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) BME SPEED(TM) IMPLANT KIT 13 X 10 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10577023 ↗
• MalfunctionJan 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) SPEED COMPRESSION IMPLANT KIT AND ONE (1) SPEED COMPRESSION SET WERE COMPROMISED UPON OPENING. THE STAPLE FELL OFF THE HANDLE IN THE PACKAGE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT IMPACT AS THERE WAS AN ADDITIONAL ONE. THIS REPORT IS FOR ONE SPEED COMPRESSION IMPLANT KIT 13X10X10MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9588134 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ARTHROSIS WAS THE REASON FOR ORIGINAL IMPLANT SURGERY.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9325242 ↗
• MalfunctionAug 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE TIBIA MEDIAL MALLEOLUS SURGERY USING THE BME CONTINUOUS COMPRESSION IMPLANTS (CCI) SPEED COMPRESSION IMPLANT KIT. THE CCI IMPLANT CAME OFF THE INSERTION HANDLE WHEN INSERTING INTO THE DISTAL TIBIA. THE SURGEON TRIED TO RE-ASSEMBLE ONTO INSERTION HANDLE WITH LAMINA SPREADER, HOWEVER, IT DOES NOT WORK. THE SURGEON INSERTED A CCI IMPLANT INTO THE BONE WITH LAMINA SPREADER HOLDING IMPLANT LEGS APART. ON FINAL BONE REDUCTION EVALUATION, THE FRACTURE WAS NOT ALIGNED PROPERLY. THE CCI IMPLANT WAS REMOVED. FRACTURE RE-REDUCED. ANOTHER CCI IMPLANT OF THE SAME SIZE WAS USED WITHOUT INCIDENT MAINTAINING PERFECT REDUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTES SURGICAL DELAY. THE PATIENT OUTCOME AS PLANNED. CONCOMITANT DEVICE REPORTED: UNKNOWN LAMINA SPREADER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 13 X 10 X 10MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8932503 ↗