Speed Shift SE-2020-08Recalls & reported problems
Synthes GmbH · Speed Shift 20x20x20 Offset 08mm Implant · Class 2 · Implant
All models of Speed Shift (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810633020487), received between Nov 29, 2018 and Sep 22, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 16, 2026.
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2021Break; Break
IT WAS REPORTED THAT ON AN (B)(6) 2021, PATIENT UNDERWENT A SURGICAL PROCEDURE. IMPLANT WAS DEPLOYED OFF, PRIOR TO BEING INSERTED INTO THE BONE AND THE IMPLANT FELL ON THE FLOOR. THUS THE SAME IMPLANT COULD NOT BE USED AND AN ADDITIONAL IMPLANT OF THE SAME SIZE WAS USED IN ITS PLACE. THE IMPLANT WAS NOT RECOVERED, AND CANNOT BE RETURNED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK: DRILL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) SPEED SHIFT 20X20X20 OFFSET 08MM IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12512238 ↗MalfunctionNov 29, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT ON (B)(6) 2018, THAT THE TWO (2) SPEEDSHIFT COMPRESSION IMPLANT KIT/CONTINUOUS COMPRESSION IMPLANT (CCI) WERE INSPECTED BEFORE THE CASE, AND THE CCI WAS NOT PROPERLY ATTACHED TO THE INSERTER INSIDE THE STERILE BOX. ONE IS BROKEN AND THE OTHER HAS CCI OFF THE INSERTER. THERE WAS NO PATIENT INVOLVEMENT. DURING PRELIMINARY INVESTIGATION OF THE RETURNED DEVICES IT WAS OBSERVED THAT BOTH INSERTERS BROKE ON THE RIGHT ISLAND FEATURE. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMPRESSION IMPLANT KIT 20X20X20MM OFFSET 8MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8118062 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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