VOLT 02.527.320Recalls & reported problems
Synthes GmbH · 2.7MM VOLT(TM) LOCKING SCREW 20MM T8 · Class 2 · Implant
All models of VOLT (66)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982333391), received between Jun 1, 2026 and Sep 15, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Device-Device Incompatibility
It was reported that the 2.4/2.7 2C VDR PLATE 6H HD/3H/RT/NRW/53 and VOLT Lock Scr ø2.7 T8 L20 SSt were involved in an intra-operative event during fixation of a distal radius fracture using the VOLT wrist system. A 2.7 mm x 20 mm locking screw was manually inserted but did not lock despite multiple attempts. The plate was removed, another plate was selected, and the procedure was completed. No patient harm or significant delay was reported. The plate was identified as available for return, and the screw was discarded. The implant was removed during the procedure and replaced with another plate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774619 ↗MalfunctionJun 1, 2026Device-Device Incompatibility
IT WAS REPORTED MULTIPLE SCREWS WOULD NOT LOCK INTO THE PLATE. DIFFERENT LOCKING GUIDES AND TRAJECTORIES OF THE DRILL WAS TRIED. THEY ALSO TRIED A NEW PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FORTY-FIVE MINUTE DELAY, BUT IT WAS NOTED THE FIXATION WAS SUBOPTIMAL, BUT NOT OTHER MEDICAL INTERVENTION WAS NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350524 ↗
Other Screw, fixation, bone devices
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- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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