SYNFIX Evolution 03.835.049Recalls & reported problems
Synthes GmbH · SCREW LOADING STATION FOR SYNFIX® EVOLUTION · Class 1
All models of SYNFIX Evolution (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034814148), received between May 8, 2019 and May 8, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
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
- Contamination /Decontamination Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE SYNFIX EVOLUTION SET, STANDARD INSTRUMENTS-EVAL WAS USED IN SURGERY ON (B)(6) 2019. ON (B)(6) 2019, FIELD STOCKING LOCATION (FSL) WAS INFORMED THAT THE SET WAS READY FOR PICK UP ON THAT DATE. THE SCREW LOADING STATION FOR SYNFIX EVOLUTION, SYNFIX EVOLUTION AWL/WITHOUT SLEEVE, HANDLE WITH QUICK COUPLING-SMALL, AND TWO (2) SYNFIX EVOLUTION SCREWDRIVER WITHOUT THREAD LOCK SLEEVE WAS PICKED UP BY OWENS AND MINORS. UPON INSPECTION, QWENS AND MINORS FOUND BLOOD ON THE PARTS OF THE SET AND REPORTED TO FSL. IT WAS FURTHER CLARIFIED THAT THESE ARE INSTRUMENT TRAYS USED BY FSAL AND THE TRAYS WERE DISCOVERED TO BE "SOILED". THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SCREW LOADING STATION FOR SYNFIX EVOLUTION. THIS IS REPORT 1 OF 5 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8591917 ↗
Other TRAY, SURGICAL devices
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- MEDLINE DYNDH1534Medline Industries, Inc. · TRAY, SURGICAL3 recalls0 reports
- MEDLINE DYNDH1470BMedline Industries, Inc. · TRAY, SURGICAL3 recalls0 reports
- Centurion MNS11625Centurion Medical Products Corporation · TRAY, SURGICAL3 recalls0 reports
- MEDLINE DYKM1756AMedline Industries, Inc. · TRAY, SURGICAL2 recalls0 reports
- MEDLINE SPEC0291BMedline Industries, Inc. · TRAY, SURGICAL2 recalls0 reports
- MEDLINE DYNDC3188Medline Industries, Inc. · TRAY, SURGICAL2 recalls0 reports
- MEDLINE DYNDH1542Medline Industries, Inc. · TRAY, SURGICAL2 recalls0 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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