Speed Arc SE-111512ARecalls & reported problems
Synthes GmbH · SPEED ARC 11X15X12mm Implant · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810633021422), received between Aug 11, 2016 and May 6, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
Device problems
- Break3
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2022Break; Difficult to Advance; Break; Difficult to Advance
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SURGEON TRIED TO PLACE SPEEDARC IMPLANT MEDIALLY. EVERYTHING WENT ACCORDING TO STG UP UNTIL THE FIRST ASSIST. THE SURGEON NOTICED THE STAPLE INSERTER DEVICE HAD BROKEN. THIS RESULTED IN THE STAPLE DEPLOYING PREMATURELY AND COMPRESSING. WITH THE SMALL SIZE OF THIS STAPLE IT WAS UNABLE TO BE SPREAD OPEN AND RELOADED. AFTER DR. TRIED OVER AND OVER TO GET IT IN, HE WAS FORCED TO GO TO SCREW INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 20 MINUTES OF SURGICAL DELAY NOTED. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE SPEEDARC COMPRESSION IMPL KIT 11X15X12. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14305506 ↗MalfunctionOct 19, 2018Break; Break
UPDATE,10.12.2018: THE DEVICES INVOLVED IN THIS COMPLAINT WERE RECEIVED BY BME ON OCT.12, 2018.
Patient problems: No Patient Involvement
MAUDE report 7985025 ↗MalfunctionAug 11, 2016Break; Break
ONE SPEED ARC WAS INSERTED DURING AKIN CASE IN 2014. ONE WEEK POST INSERTION, THE HINGE BROKE AND THE DEVICE WAS EXPLANTED. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5868243 ↗
Other Staple, Fixation, Bone devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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