NA 03.527.206Recalls & reported problems
Synthes GmbH · 2.7 VOLT(TM) CRTX/LCKNG DRILL GUIDE FOR 2.0MM DRILL BITS · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982336354), received between Dec 10, 2024 and Sep 14, 2026 — classified as 10 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break7
- No Apparent Adverse Event2
- Detachment of Device or Device Component1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026No Apparent Adverse Event
It was reported on an unknown date about damaged shipment.Upon manufacturers investigation it was noted that one guide sleeve was observed detached from the weld area.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752302 ↗MalfunctionSep 8, 2026Break
Patient problems: Insufficient Information
MAUDE report 50678346 ↗MalfunctionJun 25, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THERE WAS DEFECTIVE SHIPMENT, THE DRILL GUIDE WERE BROKEN INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25623120 ↗MalfunctionMay 5, 2026Material Integrity Problem
IT WAS REPORTED THAT THE PRODUCT IS DAMAGED. NO FURTHER INFORMATION IS PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED PHOTO IT WAS IDENTIFIED THAT VOLT DBLE DRILL GUIDE F/DRILL BITS Ø2 HAS BROKEN AT THE SLEEVE PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083367 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED ON MARCH 14, 2026 DURING AN ORIF OF FEMUR THE DRILL GUIDE BROKE AND WAS UNABLE TO USE. ALSO, VOLT DEPTH GAUGE STEM WAS BENT BEYOND REPAIR. BOTH INSTRUMENTS WERE REPLACED FROM OTHER SETS QUICKLY WITH MINIMAL DELAY TO THE CASE PATIENT OUTCOME WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758052 ↗MalfunctionNov 21, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE "LOCKING END" OF THE DRILL GUIDE BROKE OFF AND SEPARATED FROM THE HANDLE DURING OPEN REDUCTION INTERNAL FIXATION OF A DISTAL RADIUS BONE. SINCE A SECOND SET WAS ALREADY OPEN, ANOTHER INSTRUMENT WAS TAKEN FROM IT. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23622401 ↗MalfunctionSep 15, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025, THE DRILL SLEEVE PORTION OF THE DRILL GUIDE BROKE OFF FROM THE HANDLE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058133 ↗MalfunctionJul 29, 2025Break; Break
IT WAS REPORTED THAT, ON (B)(6) 2025, IN A SCREW REMOVAL CASE, THE SCREW REMOVAL HANDLES WERE DAMAGED WHEN REMOVING THE IMPLANT AND DISCARDED. WHEN PUTTING HARDWARE BACK IN THE VOLT 2.7 LOCKING/ NON LOCKING GUIDE WAS BROKEN AND DISCARDED. ITEM WERE DAMAGED AND DISCARDED INTRAOPERATIVELY. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22641796 ↗MalfunctionJun 17, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT IT WAS NOT IN A HOSPITAL SETTING AND ONLY WITH A DISPLAY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22234519 ↗MalfunctionDec 10, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO OTHER MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892973 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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