Elite EL-3020S4Recalls & reported problems
Synthes GmbH · ELITE 30x20x20mm, Straight Bridge, 4 Legs · Class 2 · Implant
All models of Elite (10)
Data updated Oct 18, 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 00810633021712), received between Sep 6, 2022 and Nov 12, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 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 OF INSERTER, NOT ALLOWING IT TO BE DEPLOYED IN THE PATIENT PROPERLY. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20666612 ↗MalfunctionSep 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ON 12 AUGUST, 2022 THE STAPLE WAS OFF THE INSERTION HANDLE WHEN THE BOX WAS OPENED. THERE WAS NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) ELTE COMP IMPL KIT 30X20X20X20X20 4 LEGS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15363322 ↗
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- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
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- 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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