Speed SE-0910Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00810633020111), received between Jun 5, 2018 and Nov 27, 2024 — classified as 7 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 27, 2022Open, Classified

   The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

   Z-0100-2023 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THERE WAS INCORRECT DRILL GUIDE INSIDE PACKAGE. THERE WAS NO OPERATION INVOLVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795386 ↗
• MalfunctionAug 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JULY 18, 2024, THREE (3) SPEED STAPLES RELEASED/DEPLOYED EARLY FROM INSERTION HANDLE. THERE WAS NO PATIENT CONSEQUENCES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) SPEED 9X10X10MM IMPLANT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048837 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THREE (3) SPEED STAPLES RELEASED/DEPLOYED EARLY FROM INSERTION HANDLE. THERE WAS NO PATIENT CONSEQUENCES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) SPEED 9X10X10MM IMPLANT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041449 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS A FEW MINUTES OF SURGICAL DELAY REPORTED AND THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038802 ↗
• MalfunctionNov 30, 2023Break; Break

  IT WAS REPORTED THAT ON NOV 8, 2023, THE LEG OF THE GUIDE BROKE OFF OF THE HAMMERTOE STAPLE GUIDE, AND THE STAPLE POPPED OFF OF THE INSERTER ON THE KIT. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242311 ↗
• MalfunctionNov 7, 2023Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2023, BOTH STAPLES DEPLOYED EARLY AND WOULD NOT FULLY SEAT. THERE WAS A SURGICAL DELAY OF 45 MINUTES TO TAKE OUT AND REIMPLANT THE DEVICE. IT HAD TO BE CUT IN HALF AND REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE SPEED 9X10X10MM IMPLANT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18082838 ↗
• MalfunctionNov 7, 2023Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2023, BOTH STAPLES DEPLOYED EARLY AND WOULD NOT FULLY SEAT. THERE WAS A SURGICAL DELAY OF 45 MINUTES TO TAKE OUT AND REIMPLANT THE DEVICE. IT HAD TO BE CUT IN HALF AND REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE SPEED 9X10X10MM IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18082836 ↗
• MalfunctionOct 14, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE BME SPEED- SE-0910 WRONG DRILL GUIDE STERILE PACKAGED WITH THE STAPLE, THE SURGEON WANTED TO USE THE 9X10 SPEED STAPLE, THE IMPLANT WAS OPENED, AND DRILL GUIDE WAS USED ONLY LATER TO REALIZE IT WAS A BIGGER SIZE THAN THE IMPLANT, SURGEON HAD TO CONVERT TO A LARGER IMPLANT. THERE WAS NO SURGICAL DELAY. THE SURGERY COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE. THIS REPORT INVOLVES ONE (1) SPEED 9X10X10MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607985 ↗
• MalfunctionOct 5, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE FACILITY OPENED A SE-0910 CCI INTRA-OP. THE PA NOTICED THE SIZE 13-DRILL GUIDE WAS INCLUDED IN THE SE-0910. THIS WAS BEFORE IT WAS DRILLED THROUGH AND USED ON THE PATIENT. AFTER FURTHER INSPECTION, THE REST HAD SIZE 13 DRILL GUIDES INCLUDED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY OF 10 MINUTES. NO PATIENT CONSEQUENCES WAS THERE. CONCOMITANT DEVICE REPORTED: UNK - GUIDE/COMPRESSION/K-WIRES(PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545720 ↗
• MalfunctionOct 5, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE FACILITY OPENED A SE-0910 CCI INTRA-OP. THE PA NOTICED THE SIZE 13-DRILL GUIDE WAS INCLUDED IN THE SE-0910. THIS WAS BEFORE IT WAS DRILLED THROUGH AND USED ON THE PATIENT. AFTER FURTHER INSPECTION, THE REST HAD SIZE 13 DRILL GUIDES INCLUDED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY OF 10 MINUTES. NO PATIENT CONSEQUENCES WAS THERE. CONCOMITANT DEVICE REPORTED: UNK - GUIDE/COMPRESSION/K-WIRES(PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545679 ↗
• MalfunctionOct 5, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE FACILITY OPENED A SE-0910 CCI INTRA-OP. THE PA NOTICED THE SIZE 13-DRILL GUIDE WAS INCLUDED IN THE SE-0910. THIS WAS BEFORE IT WAS DRILLED THROUGH AND USED ON THE PATIENT. AFTER FURTHER INSPECTION, THE REST HAD SIZE 13 DRILL GUIDES INCLUDED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY OF 10 MINUTES. NO PATIENT CONSEQUENCES WAS THERE. CONCOMITANT DEVICE REPORTED: UNK - GUIDE/COMPRESSION/K-WIRES(PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545665 ↗
• MalfunctionOct 5, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE FACILITY OPENED A SE-0910 CCI INTRA-OP. THE PA NOTICED THE SIZE 13-DRILL GUIDE WAS INCLUDED IN THE SE-0910. THIS WAS BEFORE IT WAS DRILLED THROUGH AND USED ON THE PATIENT. AFTER FURTHER INSPECTION, THE REST HAD SIZE 13 DRILL GUIDES INCLUDED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY OF 10 MINUTES. NO PATIENT CONSEQUENCES WAS THERE. CONCOMITANT DEVICE REPORTED: UNK - GUIDE/COMPRESSION/K-WIRES(PART# UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545566 ↗
• MalfunctionSep 29, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING INCOMING INSPECTION ON (B)(6) 2022, THE IMPLANT KITS WERE FOUND TO CONTAIN DRILL GUIDES FOR 13MM CCI IMPLANTS, AND NOT FOR THE 9MM CCI IMPLANT THAT IS PACKAGED. THERE WAS NO PATIENT INTERACTION, NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SPEED 9X10X10MM IMPLANT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508529 ↗
• MalfunctionSep 29, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING INCOMING INSPECTION ON (B)(6) 2022, THE IMPLANT KITS WERE FOUND TO CONTAIN DRILL GUIDES FOR 13MM CCI IMPLANTS, AND NOT FOR THE 9MM CCI IMPLANT THAT IS PACKAGED. THERE WAS NO PATIENT INTERACTION, NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SPEED 9X10X10MM IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508443 ↗
• MalfunctionSep 20, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED ON (B)(6) 2022, THAT THE INVENTORY WAS RECEIVED. INSPECTED IMPLANT PACKAGING AND NOTICED THE DRILL GUIDE IS FOR A 13MM CCI IMPLANT AND NOT FOR THE 9MM CCI IMPLANT THAT IS PACKAGED. THERE WAS NO SURGERY AT THE TIME OF DISCOVERY.THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457558 ↗
• MalfunctionSep 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AUGUST 16, 2022, THE STAPLE SPEED COMPRESSION IMPLANT KIT 09X10X10MM WAS OFF THE HANDLE. THIS WAS DISCOVERED BEFORE THE SURGERY WHILE GOING THROUGH INVENTORY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE SPEED 9X10X10MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393500 ↗
• MalfunctionJan 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPEED COMPRESSION IMPLANT WAS INCOMPATIBLE WITH THE INSERTION HANDLE. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156149 ↗
• InjuryDec 2, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH A SPEED COMPRESSION IMPLANT KIT STAPLE CCI. DURING THAT TIME, IT WAS DETERMINED THROUGH A PATIENT CHART REVIEW THAT THE PATIENT HAD A NICKEL ALLERGY. SURGEON THEN DETERMINED THAT THE CCI SHOULD BE REMOVED. THERE IS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) BME SPEED(TM) IMPLANT KIT 9 X 10 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10935699 ↗
• InjuryApr 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, WHILE ATTEMPTING TO FIX A BUNION, THE SURGEON ATTEMPTED TO IMPLANT TWO (2) SPEED COMPRESSION IMPLANT KITS 9X10X10MM AND ONE (1) SPEED COMPRESSION IMPLANT KIT 09X07X07MM. ALL OF THE THREE DEVICES POPPED OFF THE UNKNOWN INSERTER BEFORE THEY WERE ABLE TO BE IMPLANTED. THE SURGEON ULTIMATELY CHOSE ANOTHER METHOD OF FIXATION. THERE WAS A SURGICAL DELAY OF AN UNKNOWN NUMBER OF MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1).  THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8480449 ↗
• InjuryApr 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, WHILE ATTEMPTING TO FIX A BUNION, THE SURGEON ATTEMPTED TO IMPLANT TWO (2) SPEED COMPRESSION IMPLANT KITS 9X10X10MM AND ONE (1) SPEED COMPRESSION IMPLANT KIT 09X07X07MM. ALL OF THE THREE DEVICES POPPED OFF THE UNKNOWN INSERTER BEFORE THEY WERE ABLE TO BE IMPLANTED. THE SURGEON ULTIMATELY CHOSE ANOTHER METHOD OF FIXATION. THERE WAS A SURGICAL DELAY OF AN UNKNOWN NUMBER OF MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1).  THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8480258 ↗
• InjuryApr 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, WHILE ATTEMPTING TO FIX A BUNION, THE SURGEON ATTEMPTED TO IMPLANT TWO (2) SPEED COMPRESSION IMPLANT KITS 9X10X10MM AND ONE (1) SPEED COMPRESSION IMPLANT KIT 09X07X07MM. ALL OF THE THREE DEVICES POPPED OFF THE UNKNOWN INSERTER BEFORE THEY WERE ABLE TO BE IMPLANTED. THE SURGEON ULTIMATELY CHOSE ANOTHER METHOD OF FIXATION. THERE WAS A SURGICAL DELAY OF AN UNKNOWN NUMBER OF MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1).  THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8480252 ↗
• InjuryDec 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN AKIN OSTEOTOMY FOLLOWING A LAPIDUS PROCEDURE. WHILE THE SURGEON WAS PROCEEDING TO INSERT THE SPEED COMPRESSION IMPLANT KIT, THE STAPLE PREMATURELY CAME OFF OF THE INSERTER AND DISRUPTED CORTICAL BONE WHERE PREDRILLED. THIS PREMATURE DISENGAGEMENT OF THE SPEED COMPRESSION IMPLANT KIT STAPLE WAS ALSO REPORTED AS OCCURRING BEFORE. THEY STATED THAT THE CURRENT STAPLES SEEM TO HAVE A LOADING DIFFERENCE BECAUSE OF THE PRESSURE NEEDED TO RELEASE FROM THE INSERTER. THE SURGEON HAD TO SWITCH TO USING CANNULATED SCREWS INSTEAD. PROCEDURE OUTCOME IS UNKNOWN. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 09X10X10MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8170983 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY DUE TO MALUNION. TWO (2) SPEED COMPRESSION IMPLANTS WERE ORIGINALLY IMPLANTED ON (B)(6) 2018. DEVICES WERE REMOVED AND REVISED WITH A PLATE AND SCREWS. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7568980 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY DUE TO MALUNION. TWO (2) SPEED COMPRESSION IMPLANTS WERE ORIGINALLY IMPLANTED ON (B)(6) 2018. DEVICES WERE REMOVED AND REVISED WITH A PLATE AND SCREWS. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7568971 ↗