VOLT 02.420.120Recalls & reported problems
Synthes GmbH · 2.0MM VOLT(TM) CORTEX SCREW 20MM T6 · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982314567), received between Jul 28, 2025 and Jul 28, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance2
Patient problems
- Bone Fracture(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE SURGEON WAS USING A 2.0 STRAIGHT PLATE (02.420.008) ACROSS THE CUBOID-4TH METATARSAL JOINT. SURGEON DRILLED WITH A 1.5 VOLT DRILL BIT AND INSERTED A 2.0X20MM CORTEX SCREW, WHICH CONTINUED TO SPIN. SURGEON REDRILLED A NEW HOLE, ENSURING THAT HE DRILLED BICORTICAL, REMEASURED & ATTEMPTED TO INSERT A DIFFERENT 2.0X20MM CORTEX SCREW WHICH AGAIN CONTINUED TO SPIN. SURGEON ATTEMPTED A 3RD HOLE, BUT CHOSE A 2.0X20MM LOCKING SCREW, THIS SCREW CONTINUED TO SPIN, AND THE CUBOID THEN SHATTERED. SURGEON REMOVED ALL VOLT PRODUCTS AND FIXATED WITH K-WIRES. FRAGMENTS WERE GENERATED WHICH COULD NOT BE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION, CAPTURED WITH K WIRES & SPLINTED.
Patient problems: Bone Fracture(s)
MAUDE report 22629638 ↗InjuryJul 28, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE SURGEON WAS USING A 2.0 STRAIGHT PLATE (02.420.008) ACROSS THE CUBOID-4TH METATARSAL JOINT. SURGEON DRILLED WITH A 1.5 VOLT DRILL BIT AND INSERTED A 2.0 X 20 MM CORTEX SCREW, WHICH CONTINUED TO SPIN. SURGEON REDRILLED A NEW HOLE, ENSURING THAT HE DRILLED BICORTICAL, REMEASURED & ATTEMPTED TO INSERT A DIFFERENT 2.0 X 20 MM CORTEX SCREW WHICH AGAIN CONTINUED TO SPIN. SURGEON ATTEMPTED A 3RD HOLE, BUT CHOSE A 2.0 X 20 MM LOCKING SCREW, THIS SCREW CONTINUED TO SPIN, AND THE CUBOID THEN SHATTERED. SURGEON REMOVED ALL VOLT PRODUCTS AND FIXATED WITH K-WIRES. FRAGMENTS WERE GENERATED WHICH COULD NOT BE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION, CAPTURED WITH K WIRES & SPLINTED.
Patient problems: Bone Fracture(s)
MAUDE report 22629510 ↗
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- 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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