NA 394.075Recalls & reported problems
Synthes GmbH · DISTRACTOR FOR DISTAL RADIUS FIXATOR · 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 10886982199553), received between Feb 3, 2026 and Feb 3, 2026 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionFeb 3, 2026Break
IT WAS REPORTED THAT PIECES WERE BREAKING OFF INSIDE THE PART. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT DID NOT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24250786 ↗
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- NA 72201725Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.