Speed SE-0907Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810633020104), received between Feb 12, 2016 and Sep 11, 2023 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719981 ↗
• MalfunctionJun 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE STAPLE FELL OFF PRIOR TO SURGEON INSERTING INTO BONE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH DELAY OF 2 MINUTES. THERE WAS NO FRAGMENTS GENERATED AND NO PATIENT CONSEQUENCES. THIS COMPLAIN INVOLVES ONE(1) DEVICE SPEED COMPRESSION IMPLANT KIT 09X07X07MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14845616 ↗
• MalfunctionJan 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING ROUTING INSPECTION, A BME SPEED IMPLANT KIT STAPLE APPEARED TO HAVE ACCIDENTALLY DEPLOYED INSIDE THE PACKAGING. THERE WAS NO PATIENT AND SURGICAL PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) BME SPEED(TM) IMPLANT KIT 9 X 7 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156477 ↗
• MalfunctionDec 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE RESTOCKING THE TOTE, IT WAS NOTICED THAT THE STAPLE OF THE SPEED COMPRESSION IMPLANT KIT WAS NOT CONNECTED TO THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X07X07MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088257 ↗
• MalfunctionFeb 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  03/25/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, IT WAS NOTICED THAT THE SPEED COMPRESSION IMPLANT STAPLE HAD DISENGAGED FROM THE HANDLE. A SECOND STAPLE WAS USED INSTEAD TO PROCEED WITH THE CASE. THERE WERE NO ADVERSE EVENTS NOTED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359496 ↗
• InjuryOct 10, 2018Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2018, A PROXIMAL INTERPHALANGEAL (PIP) JOINT FUSION SURGERY OF THE FIFTH FINGER WAS PERFORMED. THE SURGEON ATTEMPTED TO FUSE THE PROXIMAL ENTER FELL AND JILL JOINT OF THE FIFTH METACARPAL ON THE RIGHT-HAND SIDE OF THE PATIENT. THE SURGEON WAS GOING TO USE THE 20907 STAPLES TO FUSE THE JOINT BUT, WHEN THE STAPLES WERE REMOVED FROM THE PACKAGING, THEY HAD DISENGAGED FROM THE INSERTER AND WERE NOT ABLE TO BE USED FOR THE PROCEDURE. ANOTHER STAPLE OF THE SAME SIZE WAS THEN USED TO HOLD A REDUCTION AND THE SURGEON THEN DECIDED TO REMOVE THE STAPLE AND USE 2K WIRES TO COMPLETE THE SURGERY. THERE WAS A FIVE-MINUTE SURGICAL DELAY. PATIENT AND SURGICAL OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X07X07MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7953557 ↗
• 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 5435285 ↗