NA 04.633.294Recalls & reported problems
Synthes GmbH · 5.5MM TI HARD ROD 400MM · Class 2 · Implant
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 10705034746555), received between Mar 11, 2022 and Mar 12, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
Most reported problems
Device problems
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT, THE 5.5 PRECON ROD 80MM STR LEN/400MM AND 5.5MM TI HARD ROD 400MM WERE FOUND BROKE, DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5.5MM TI HARD ROD 400MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 13742704 ↗MalfunctionMar 11, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ROD WAS DISCOVERED AS BROKEN DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5MM TI HARD ROD 400MM THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13733788 ↗
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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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