SpeedRecalls & reported problems across all models
Synthes GmbH · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Speed model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 79
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 2
We found 10 models of Speed by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 79 adverse event reports in the FDA's MAUDE database, received between Feb 12, 2016 and Mar 2, 2026 — classified as 15 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (33 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Speed recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 27, 2022Class IIOpen, 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 · Recall details · FDA record ↗
- Sep 27, 2022Class IIOpen, 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-0099-2023 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported Speed problems
Device problems
- Detachment of Device or Device Component33
- Manufacturing, Packaging or Shipping Problem12
- Adverse Event Without Identified Device or Use Problem10
- Break8
- Device-Device Incompatibility8
- Difficult to Advance5
- Failure to Cut2
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Consequences Or Impact To Patient14
- No Code Available11
- No Patient Involvement5
- Bone Fracture(s)3
- Insufficient Information3
- No Known Impact Or Consequence To Patient2
- Nonunion/Delayed-union Bone Fracture2
Speed models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Speed SE-0910Staple, Fixation, Bone1 recall24 reports
- Speed SE-1512Staple, Fixation, Bone1 recall6 reports
- Speed SE-1110Staple, Fixation, Bone17 reports
- Speed SE-1310Staple, Fixation, Bone10 reports
- Speed SE-0907Staple, Fixation, Bone7 reports
- Speed SE-1308Staple, Fixation, Bone4 reports
- Speed SE-1312Staple, Fixation, Bone4 reports
- Speed SE-1108Staple, Fixation, Bone3 reports
- Speed SE-1510Staple, Fixation, Bone3 reports
- Speed SE-131513Staple, Fixation, Bone1 report
Recent Speed adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE COMPRESSIVE FORCE OF THE STAPLE IMPLANT CAUSED AN IATROGENIC FRACTURE OF THE PATIENT'S BIG TOE. IT WAS QUESTIONED WHETHER POOR BONE QUALITY, DRILLING TECHNIQUE, OR THE IMPLANT WAS THE CAUSE OF THE IATROGENIC FRACTURE. THE SURGEON ELECTED TO REMOVE THE STAPLE AND USED A K-WIRE FOR FIXATION INSTEAD. THE PROCEDURE WAS COMPLETED WITH A FIFTEEN MINUTE DELAY. THIS REPORT IS FOR A SPEED 11X8X8MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 19995838 ↗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 ↗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 ↗MalfunctionSep 11, 2023Device-Device Incompatibility; Device-Device Incompatibility
THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17719981 ↗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 ↗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 ↗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 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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