SynFrame 387.335Recalls & reported problems
Synthes GmbH · SYNFRAME HOLDING RING-SMALL 2 PIECE-240MM DIAMETER · Class 1
- 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 10705034771045), received between Aug 26, 2025 and Aug 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Compatibility 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Compatibility Problem1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW WAS LOOSE ON THE SYNFRAME HOLDING RING Ø240. NO HIDER WAS ENCOUNTERED DURING THE OPERATING ROOM. IT WAS DIFFICULT TO ASSEMBLE BEFORE THE OPERATING ROOM, AND AFTER THE OPERATION, THE SCREW WAS LOOSE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22892958 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.