RONDO' Screw ø4mm L45mmRecalls & reported problems
Citieffe Srl · Titanium cannulated screw ø4mm L45mm with washer. Material: titanium alloy Ti6Al4V ELI (ASTM F136). · Class 2
Data updated Oct 18, 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 08032909622436), received between Mar 11, 2020 and Mar 11, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2020Break
THE SCREW BROKE DURING THE SURGERY, IN PARTICULAR DURING THE SCREWING INTO THE PATELLA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9817107 ↗
Other Pin, Fixation, Smooth devices
- RIGIDFIX 210133Medos International Sàrl · PIN, FIXATION, SMOOTH91 reports
- SMART TOE ST0A-16PStryker GmbH · PIN, FIXATION, SMOOTH1 recall5 reports
- SMART TOE ST0-19PStryker GmbH · PIN, FIXATION, SMOOTH1 recall2 reports
- Flower E-Kit, Advanced EWK 201Flower Orthopedics Corporation · Pin, Fixation, Smooth1 recall0 reports
- Brasseler USA 5007972M0Peter Brasseler Holdings, LLC · PIN, FIXATION, SMOOTH1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 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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