NA 03.424.186Recalls & reported problems
Synthes GmbH · 2.4 VOLT(TM) CRTX/LCKNG DRILL GUIDE FOR 1.8MM DRILL BITS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982336262), received between Dec 2, 2024 and Mar 17, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Break
THE DRILL GUIDE SNAPPED OFF AND NEEDS TO BE REPLACED. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617103 ↗MalfunctionJul 3, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE USING THE VOLT MINI FRAG FOR AN ORTHOPEDIC FRACTURE ORIF, THE 1.8MM/2.4MM DRILL GUIDE BROKE. THE DRILL TUBE BROKE FROM THE HANDLE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393625 ↗MalfunctionJun 25, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025, DURING CLEANING OF THE DRILL GUIDE, IT BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331298 ↗MalfunctionMay 6, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DRILL GUIDE FROM THE VOLT MINI FRAGMENT SET ARRIVED BROKEN. THE 2.4 NON-LOCKING DRILL GUIDE PORTION OF GUIDE WAS FOUND BROKEN CLEAN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21971623 ↗MalfunctionApr 29, 2025Break; Break
IT WAS REPORTED THAT THE 1.8/2.4 VOLT DRILL GUIDE SHIPPED BROKEN IN PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926709 ↗MalfunctionMar 11, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE STEM OF THE DRILL GUIDE HAS SHEARED OFF. THE PRODUCT IS STILL IN ORIGINAL PACKAGING. SET HAS NEVER BEEN TO THE HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575733 ↗MalfunctionDec 2, 2024Break; Break
IT WAS REPORTED THAT THE USER WAS REPLENISHING SETS AND ONE OF THE PARTS WAS BROKEN WHEN RECEIVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20818907 ↗
Other Guide, surgical, instrument devices
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- 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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