Speed TitanRecalls & reported problems across all models
Synthes GmbH · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 6 models of Speed Titan by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2016 and May 21, 2025 — classified as 4 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Break” (19 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. 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
Most reported Speed Titan problems
Device problems
- Break19
- Detachment of Device or Device Component7
- Device-Device Incompatibility5
- Manufacturing, Packaging or Shipping Problem3
- Adverse Event Without Identified Device or Use Problem2
- Device Damaged by Another Device2
- Inaccurate Information2
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient3
- No Patient Involvement3
- Failure of Implant2
- Bone Fracture(s)1
- Hypersensitivity/Allergic reaction1
- Insufficient Information1
Speed Titan models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Speed Titan SE-1515TIStaple, Fixation, Bone18 reports
- Speed Titan SE-2520TIStaple, Fixation, Bone11 reports
- Speed Titan SE-1815TIStaple, Fixation, Bone5 reports
- Speed Titan SE-1818TIStaple, Fixation, Bone2 reports
- Speed Titan SE-2020TIStaple, Fixation, Bone2 reports
- Speed Titan SE-2015TIStaple, Fixation, Bone1 report
Recent Speed Titan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Break; Break
IT WAS REPORTED THAT THE SURGEON WAS PREPARING TO IMPLANT THE PRODUCT IN QUESTION, BUT SHORTLY AFTER OPENING AND BEFORE APPLYING THE IMPLANT PROCEDURE, HE REALIZED THAT THE PLASTIC INSERTER WAS BROKEN AND DEFECTIVE, SO HE WAS UNABLE TO USE THE IMPLANT ON THE PATIENT. NEW DEVICE WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22063126 ↗InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SURGEON HAD TO REMOVE THE STAPLES FROM 5 OF 10 OTHER PATIENTS BECAUSE OF A REACTION. HE BELIEVES IT'S NOT AN INFECTION DISEASE CONCERN BUT MORE WITH THE CONTENT OF NICKEL GOING FROM A LIGHT GRAY IN COLOR TO A DARK GRAY IN COLOR. PATIENT OUTCOME IS REPORTED AS DOING WELL WITHOUT PROBLEMS. FINDINGS: ARTHRITIC BONE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21414731 ↗MalfunctionMar 4, 2024Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT ON (B)(6) 2023, THE INSERTION HANDLE WAS CRACKED WHEN THE IMPLANT WAS OPENED ONTO THE SURGICAL FIELD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 10 MINUTES. THEY HAD USED A DIFFERENT IMPLANT. THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPL KIT 25X20X20 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18828093 ↗MalfunctionFeb 20, 2024Break; Break
DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A FOOT SURGERY ON (B)(6) 2024, THE PLACEMENT INSTRUMENT OF TWO SPEED TITAN COMPRESSION IMPLANT KITS BROKE OFF. THE DOCTOR HAD TO USE FORCEPS TO INSERT THE IMPLANTS. THE DEFECTIVE PLACEMENT INSTRUMENTS WERE THROWN AWAY. NO FRAGMENTS REMAINED IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO HARM TO PATIENT OR USER. NO ADDITIONAL SURGICAL INTERVENTION PLANNED. THIS REPORT IS FOR A SPEED TITAN COMPRESSION IMPL KIT 25X20X20. THIS IS REPORT 1 OF 2 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18743933 ↗MalfunctionNov 10, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT ON (B)(6) 2023 WHILE CONDUCTING AUDITS, ITEMS LABELED A SPECIFIC ITEM NUMBER WERE LABELED DIFFERENTLY ON THE BACK OF THE BOX. THE BARCODE NUMBER APPEARS AS A DIFFERENT ITEM. NO SURGICAL DELAY. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SPEEDTITAN COMPRESSION IMPL KIT 18X15X15 THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18116914 ↗MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT ON (B)(6) 2023 WHILE CONDUCTING AUDITS, IT WAS DISCOVERED THAT THE ITEM IN QUESTION LABELED WITH A SPECIFIC ITEM NUMBER WAS LABELED DIFFERENTLY ON THE BACK OF THE BOX. THE BARCODE NUMBER APPEARS AS A DIFFERENT ITEM. THERE WAS NO REPORTED PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A SPEED TITAN 18X15X15MM IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17940356 ↗MalfunctionAug 18, 2023Break; Break
IT WAS REPORTED THAT DURING SURGERY ON (B)(4) 2023, THE INSERTION HANDLE OF A SPEEDTITAN CCI STAPLE IMPLANT KIT WAS FOUND TO BE BROKEN AFTER IT WAS OPENED FROM ITS STERILE PACKAGE. THE PRONGS OF THE STAPLE LOST THEIR LOADED TENSION AND IT DID NOT FIT IN THE DRILL HOLES FROM THE DRILL GUIDE INCLUDED WITH THE KIT. ANOTHER CCI STAPLE OF THE SAME TYPE WAS OPENED AND USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE SPEED TITAN 25X20X20MM IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17572817 ↗MalfunctionApr 19, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION TOOL CONTAINING THE SPEEDTITAN IMPLANT WAS BROKEN DESPITE THE PACKAGING BEING CORRECT AND UNDAMAGED. THE DOCTOR ORDERED ANOTHER IMPLANT OF THE SAME PART AND LOT AND THE SAME EVENT WAS REPEATED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SPEED TITAN 25X20X20MM IMPLANT KIT. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16768695 ↗MalfunctionApr 19, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION TOOL CONTAINING THE SPEEDTITAN IMPLANT WAS BROKEN DESPITE THE PACKAGING BEING CORRECT AND UNDAMAGED. THE DOCTOR ORDERED ANOTHER IMPLANT OF THE SAME PART AND LOT AND THE SAME EVENT WAS REPEATED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SPEED TITAN 25X20X20MM IMPLANT KIT. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16768693 ↗MalfunctionSep 14, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE STAPLE WASN'T LOADED ONTO THE INSERTER PROPERLY AND WOULD NOT FIT INTO THE HOLES DRILLED THROUGH THE GUIDE. A DIFFERENT STAPLE WAS USED. THE SURGERY WAS COMPLETED WITH TWO TO FIVE MINUTES OF DELAY. THIS REPORT IS FOR A SPEEDTITAN COMPRESSION IMPLANT KIT 15X15. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15422003 ↗MalfunctionAug 16, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2022 PSI GROUP FAILED TO MAKE 3MM HOLES. THE EVENT DID NOT OCCUR DURING STERILE PROCESS NOR DURING FIELD INSPECTION. IT OCCURRED DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPLANT KIT 15X15 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15232481 ↗MalfunctionJun 21, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON (B)(6) 2022, THE DOCTOR WAS OPERATING ON A PATIENT THAT PRESENTED WITH A LISFRANC FRACTURE. THE SURGEON REQUESTED AN SE-1815TI BME STAPLE, BUT THE BIN ONLY HAD BOXES OF SE 181815TI STAPLES AVAILABLE. UPON FURTHER INSPECTION, IT WAS DISCOVERED THAT TWO OF THE BOXES OF SE 181815TI STAPLES ACTUALLY CONTAINED SE-1815TI STAPLES INSIDE OF THE IMPLANT BOX. THE GREY OUTER BOX SHOWS SE-181815TI, BUT THE IMPLANT STICKER WITH BARCODE READS SE-1815TI. ONE OF THE IMPLANTS WAS OPENED AND IT WAS SUCCESSFULLY IMPLANTED WITH NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS FOR A SPEED TITAN 18X15X15MM IMPLANT KIT. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14754394 ↗MalfunctionJun 21, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON (B)(6) 2022, THE DOCTOR WAS OPERATING ON A PATIENT THAT PRESENTED WITH A LISFRANC FRACTURE. THE SURGEON REQUESTED AN SE-1815TI BME STAPLE, BUT THE BIN ONLY HAD BOXES OF SE 181815TI STAPLES AVAILABLE. UPON FURTHER INSPECTION, IT WAS DISCOVERED THAT TWO OF THE BOXES OF SE 181815TI STAPLES ACTUALLY CONTAINED SE-1815TI STAPLES INSIDE OF THE IMPLANT BOX. THE GREY OUTER BOX SHOWS SE-181815TI, BUT THE IMPLANT STICKER WITH BARCODE READS SE-1815TI. ONE OF THE IMPLANTS WAS OPENED AND IT WAS SUCCESSFULLY IMPLANTED WITH NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS FOR A SPEED TITAN 18X15X15MM IMPLANT KIT. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14754376 ↗MalfunctionMay 3, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED BY THE SALES REP THAT DURING INVENTORY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BME SPEEDTITAN SE-2520TI IMPLANT STICKER AND IMPLANT WERE IN A SPEEDTITAN SE-2020TI BOX. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE(1) DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14270357 ↗InjuryMar 25, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2022 ONE OF THE LEGS OF A DRILLING GUIDE FOR A SPEED TITAN BROKE OFF DURING DRILLING. AN ADDITIONAL INCISION HAD TO BE MADE TO RETRIEVE THE BROKEN GUIDE WHICH TOOK ROUGHLY FIFTEEN(15)MIN AT THE END OF THE CASE. THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPL KIT 20X15X15. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Tissue Injury
MAUDE report 13903362 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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