NA 03.527.210Recalls & reported problems
Synthes GmbH · 2.7/2.0 VOLT(TM) DOUBLE DRILL GUIDE FOR 2.7MM PLATES · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982336002), received between May 21, 2025 and May 8, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, THE 2.7MM SIDE OF THE DRILL GUIDE SNAPPED OFF. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25127851 ↗MalfunctionFeb 26, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE 2.7 SIDE OF THE DRILL GUIDE WAS SNAPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461346 ↗MalfunctionMay 21, 2025Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE BROKE IN TWO PIECES DURING USE IN SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22063758 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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