VOLT 02.535.132Recalls & reported problems
Synthes GmbH · 3.5MM VOLT(TM) CORTEX SCREW 32MM T15 · 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 10886982324481), received between Sep 22, 2026 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
It was reported on an unknown date, that three (3) VOLT small frag cortex screw broke during insertion into a tibia.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948943 ↗MalfunctionSep 22, 2026Break; Entrapment of Device
It was reported that VOLT Cort Scr ø3.5 T15 L32 SSt and VOLT Cort Scr ø3.5 T15 L30 SSt were involved in a revision nonunion femur case with another company¿s reconstruction nail. After insertion of the nail, the femur was provisionally fixated to compress the nonunion. During insertion of the two 3.5 cortex screws, one in the plate and one for the articulating reduction device, the screw heads sheared off. Both broken screws remained embedded in the patient, with one retained in the plate and the other breaking during shaft extraction. The plate remained properly fixated, and no patient harm or secondary impact related to the embedded devices was reported.
Patient problems: Foreign Body In Patient
MAUDE report 50854178 ↗
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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