VOLT 02.420.006Recalls & reported problems
Synthes GmbH · 2.0MM VOLT(TM) STRAIGHT PLATE 6H/45MM · Class 2 · Implant
All models of VOLT (66)
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 10886982329332), received between Jul 21, 2025 and Jul 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
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.
MalfunctionJul 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SURGEON THAT THE PLATE REDUCTION WIRE BROKE OFF JUST DISTAL TO THE METAL BALL ON THE WIRE AS HE WAS INSERTING IT INTO THE K-WIRE HOLE IN THE PLATE. THIS RESULTED IN THE TIP OF THE WIRE BEING STUCK IN THE PLATE. THE SURGEON ELECTED TO REMOVE THE PLATE FROM THE WOUND AND SELECTED A DIFFERENT PLATE. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 2 MINUTES. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22555429 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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