VOLT 02.420.005Recalls & reported problems
Synthes GmbH · 2.0MM VOLT(TM) COMP STRGHT PL 10H/52MM · 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 10886982329318), received between Sep 15, 2025 and May 4, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Device-Device Incompatibility1
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.
MalfunctionMay 4, 2026Device-Device Incompatibility
IT WAS REPORTED THAT 2.4MM VOLT(TM) LOCKING SCREW 18MM T8, 2.4MM VOLT(TM) LOCKING SCREW 19MM T8, VOLT LOCK SCR Ø2.4 T8 L10 SST, VOLT LOCK SCR Ø2 T6 L17 SST, VOLT LOCK SCR Ø2 T6 L15 SST, 2.4 VOLT(TM) CONDYLAR PL 2H HD/6H/54MM, AND 2.0 VOLT(TM) COMP STRGHT PL 10H/52MM WERE INVOLVED IN AN EVENT DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF THE DISTAL RADIUS AND ULNA. DURING FIXATION OF THE ULNA, ONE HOLE IN EACH OF THE 2.4 VOLT CONDYLAR PLATE 6H AND 2.0 COMPACT VOLT STRAIGHT PLATE HAD DIFFICULTY ACCEPTING LOCKING SCREWS. MULTIPLE LOCKING SCREWS OF DIFFERENT LENGTHS WERE TRIED, AND THE HOLES WERE REDRILLED AT THE NOMINAL ANGLE. AFTER SEVERAL ATTEMPTS, THE HOLES EVENTUALLY ACCEPTED THE LOCKING SCREWS. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25069520 ↗MalfunctionSep 15, 2025Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT INADEQUATE STORAGE OF SCREWS IN VOLT MINI FRAG. 2.0 SPRING LOADED SOFT TISSUE PROTECTOR BROKE WHEN REMOVING POST-OP. IT IS UNKNOWN IF THE PATIENT EXPERIENCED AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. IT IS ALSO NOT KNOWN IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058332 ↗
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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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