VOLT 02.527.316Recalls & reported problems
Synthes GmbH · 2.7MM VOLT(TM) LOCKING SCREW 16MM T8 · Class 2 · Implant
All models of VOLT (66)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982334138), received between Feb 20, 2026 and Jun 1, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 Incompatibility4
- Break2
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 25350507 ↗MalfunctionApr 16, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEVICES WERE UNABLE TO BE STERILIZED OR ASSEMBLED; DEVICES WERE CHIPPING AND CRACKING. DEVICES WERE NOT USABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897313 ↗MalfunctionApr 16, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEVICES WERE UNABLE TO BE STERILIZED OR ASSEMBLED; DEVICES WERE CHIPPING AND CRACKING. DEVICES WERE NOT USABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897097 ↗MalfunctionFeb 20, 2026Device-Device Incompatibility
IT WAS REPORTED THAT SURGEON WAS TREATING A DISTAL HUMERUS FRACTURE SHOWN BELOW AND A 2.7MM VOLT LOCKING SCREW, 16MM DID NOT LOCK INTO ONE OF THE TWO HEAD HOLES OF 2.7MM VOLT CONDYLAR PLATE. ACCORDING TO SURGEON PREDRILL 2.0MM HOLE WITH SPHERICAL TIP OF DRILL GUIDE IN THE POSTERIOR LATERAL COLUMN OF DISTAL HUMERUS AND 2.7MM VOLT LOCKING SCREW, 16MM DID NOT LOCK INTO ONE OF THE HEAD HOLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402196 ↗
Other Screw, fixation, bone devices
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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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