VOLTRecalls & reported problems across all models
Synthes GmbH · 66 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 125
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 66 models of VOLT by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 125 adverse event reports in the FDA's MAUDE database, received between May 19, 2025 and Sep 30, 2026 — classified as 4 injuries, 121 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (73 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VOLT problems
Device problems
- Device-Device Incompatibility73
- Break57
- Crack32
- Material Deformation18
- Corroded6
- Entrapment of Device5
- Difficult to Advance3
- Material Twisted/Bent3
Patient problems
- No Clinical Signs, Symptoms or Conditions108
- Insufficient Information9
- Foreign Body In Patient5
- Bone Fracture(s)3
VOLT models
66 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VOLT 02.424.318Screw, fixation, bone7 reports
- VOLT 02.424.320Screw, fixation, bone7 reports
- VOLT 02.424.310Screw, fixation, bone5 reports
- VOLT 02.424.324Screw, fixation, bone5 reports
- VOLT 02.527.106Screw, fixation, bone4 reports
- VOLT 02.527.316Screw, fixation, bone4 reports
- VOLT 03.536.028Guide, surgical, instrument4 reports
- VOLT 02.424.111Screw, fixation, bone3 reports
- VOLT 02.527.112Screw, fixation, bone3 reports
- VOLT 02.527.116Screw, fixation, bone3 reports
- VOLT 02.527.175Screw, fixation, bone3 reports
- VOLT 02.527.318Screw, fixation, bone3 reports
- VOLT 02.424.069Plate, fixation, bone3 reports
- VOLT 03.536.001Guide, surgical, instrument3 reports
- VOLT 02.420.119Screw, fixation, bone2 reports
- VOLT 02.420.120Screw, fixation, bone2 reports
- VOLT 02.420.126Screw, fixation, bone2 reports
- VOLT 02.424.110Screw, fixation, bone2 reports
- VOLT 02.424.314Screw, fixation, bone2 reports
- VOLT 02.535.130Screw, fixation, bone2 reports
- VOLT 02.535.132Screw, fixation, bone2 reports
- VOLT 02.420.005Plate, fixation, bone2 reports
- VOLT 02.424.010Plate, fixation, bone2 reports
- VOLT 02.527.185Screw, fixation, bone2 reports
- VOLT 02.527.180Screw, fixation, bone2 reports
- VOLT 02.527.320Screw, fixation, bone2 reports
- VOLT 02.527.315Screw, fixation, bone2 reports
- VOLT 02.420.069Plate, fixation, bone2 reports
- VOLT 02.527.069Plate, fixation, bone2 reports
- VOLT 03.536.002Guide, surgical, instrument2 reports
- VOLT 02.538.003Plate, fixation, bone1 report
- VOLT 02.420.130Screw, fixation, bone1 report
- VOLT 02.420.132Screw, fixation, bone1 report
- VOLT 02.420.150Screw, fixation, bone1 report
- VOLT 02.420.309Screw, fixation, bone1 report
- VOLT 02.420.315Screw, fixation, bone1 report
- VOLT 02.420.317Screw, fixation, bone1 report
- VOLT 02.420.320Screw, fixation, bone1 report
- VOLT 02.420.326Screw, fixation, bone1 report
- VOLT 02.420.330Screw, fixation, bone1 report
- VOLT 02.420.338Screw, fixation, bone1 report
- VOLT 02.420.340Screw, fixation, bone1 report
- VOLT 02.420.346Screw, fixation, bone1 report
- VOLT 02.424.106Screw, fixation, bone1 report
- VOLT 02.424.108Screw, fixation, bone1 report
- VOLT 02.424.114Screw, fixation, bone1 report
- VOLT 02.424.124Screw, fixation, bone1 report
- VOLT 02.424.306Screw, fixation, bone1 report
- VOLT 02.424.311Screw, fixation, bone1 report
- VOLT 02.424.312Screw, fixation, bone1 report
- VOLT 02.424.319Screw, fixation, bone1 report
- VOLT 02.424.322Screw, fixation, bone1 report
- VOLT 02.527.114Screw, fixation, bone1 report
- VOLT 02.527.117Screw, fixation, bone1 report
- VOLT 02.535.124Screw, fixation, bone1 report
- VOLT 02.420.006Plate, fixation, bone1 report
- VOLT 02.420.010Plate, fixation, bone1 report
- VOLT 02.527.306Screw, fixation, bone1 report
- VOLT 02.527.322Screw, fixation, bone1 report
- VOLT 02.527.324Screw, fixation, bone1 report
- VOLT 02.527.390Screw, fixation, bone1 report
- VOLT 02.527.314Screw, fixation, bone1 report
- VOLT 02.424.068Plate, fixation, bone1 report
- VOLT 02.527.068Plate, fixation, bone1 report
- VOLT 02.527.071Plate, fixation, bone1 report
- VOLT 02.538.507Plate, fixation, bone1 report
Recent VOLT adverse event reports
The 15 most recent reports across all models, 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 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 50948324 ↗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 50948210 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
It was reported that a VDR plate and VOLT Lock Scr were involved in an intra-operative event during a VOLT distal radius procedure. The distal-most ulnar hole of the plate would not allow a locking screw to lock into the plate. Proper instrumentation was used, the hole was drilled at the nominal angle through the guide block with the locking drop-in guide, and the guide was heard clicking into place. When the screw threads contacted the plate, some resistance was encountered, after which the screw began spinning in the plate without resistance. No patient or user harm was reported; however, the procedure was prolonged by 10 minutes. The plate remained implanted and was not available for return, and the screw was discarded and was also unavailable for return.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931851 ↗MalfunctionSep 25, 2026Device-Device Incompatibility
It was reported that the Locking holes in plates are compromised / did not lock in surgeries. There is no surgical delay or patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897002 ↗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 50854270 ↗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 ↗MalfunctionSep 17, 2026Device-Device Incompatibility
It was reported on an unknown date, that during a surgical procedure utilizing the VOLT Distal Radius Plate, an issue was encountered with multiple locking screws failing to properly lock into the plate. Despite appropriate use of the designated guide block and following the recommended technique, the locking screws did not consistently engage and lock into the threaded holes of the plate as intended. Attempts were made to achieve proper screw engagement using the guide block; however, the screws continued to advance without achieving the expected locking mechanism. This resulted in difficulty obtaining secure screw-to-plate fixation and required removal of the plate. The product and associated instrumentation should be evaluated to determine whether there is a potential issue with the plate threads, locking screw threads, guide block alignment, or compatibility between the components.
Patient problems: Insufficient Information
MAUDE report 50805342 ↗MalfunctionSep 17, 2026Device-Device Incompatibility
It was reported on an unknown date, that during a surgical procedure utilizing the VOLT Distal Radius Plate, an issue was encountered with multiple locking screws failing to properly lock into the plate. Despite appropriate use of the designated guide block and following the recommended technique, the locking screws did not consistently engage and lock into the threaded holes of the plate as intended. Attempts were made to achieve proper screw engagement using the guide block; however, the screws continued to advance without achieving the expected locking mechanism. This resulted in difficulty obtaining secure screw-to-plate fixation and required removal of the plate. The product and associated instrumentation should be evaluated to determine whether there is a potential issue with the plate threads, locking screw threads, guide block alignment, or compatibility between the components.
Patient problems: Insufficient Information
MAUDE report 50805325 ↗MalfunctionSep 17, 2026Device-Device Incompatibility
It was reported on an unknown date, that during a surgical procedure utilizing the VOLT Distal Radius Plate, an issue was encountered with multiple locking screws failing to properly lock into the plate. Despite appropriate use of the designated guide block and following the recommended technique, the locking screws did not consistently engage and lock into the threaded holes of the plate as intended. Attempts were made to achieve proper screw engagement using the guide block; however, the screws continued to advance without achieving the expected locking mechanism. This resulted in difficulty obtaining secure screw-to-plate fixation and required removal of the plate. The product and associated instrumentation should be evaluated to determine whether there is a potential issue with the plate threads, locking screw threads, guide block alignment, or compatibility between the components.
Patient problems: Insufficient Information
MAUDE report 50805323 ↗MalfunctionSep 17, 2026Device-Device Incompatibility
Patient problems: Insufficient Information
MAUDE report 50805312 ↗MalfunctionSep 17, 2026Device-Device Incompatibility
It was reported on an unknown date, that during a surgical procedure utilizing the VOLT Distal Radius Plate, an issue was encountered with multiple locking screws failing to properly lock into the plate. Despite appropriate use of the designated guide block and following the recommended technique, the locking screws did not consistently engage and lock into the threaded holes of the plate as intended. Attempts were made to achieve proper screw engagement using the guide block; however, the screws continued to advance without achieving the expected locking mechanism. This resulted in difficulty obtaining secure screw-to-plate fixation and required removal of the plate. The product and associated instrumentation should be evaluated to determine whether there is a potential issue with the plate threads, locking screw threads, guide block alignment, or compatibility between the components.
Patient problems: Insufficient Information
MAUDE report 50805286 ↗MalfunctionSep 17, 2026Device-Device Incompatibility
It was reported on an unknown date, that during a surgical procedure utilizing the VOLT Distal Radius Plate, an issue was encountered with multiple locking screws failing to properly lock into the plate. Despite appropriate use of the designated guide block and following the recommended technique, the locking screws did not consistently engage and lock into the threaded holes of the plate as intended. Attempts were made to achieve proper screw engagement using the guide block; however, the screws continued to advance without achieving the expected locking mechanism. This resulted in difficulty obtaining secure screw-to-plate fixation and required removal of the plate. The product and associated instrumentation should be evaluated to determine whether there is a potential issue with the plate threads, locking screw threads, guide block alignment, or compatibility between the components.
Patient problems: Insufficient Information
MAUDE report 50805258 ↗MalfunctionSep 17, 2026Device-Device Incompatibility
It was reported on an unknown date, that during a surgical procedure utilizing the VOLT Distal Radius Plate, an issue was encountered with multiple locking screws failing to properly lock into the plate. Despite appropriate use of the designated guide block and following the recommended technique, the locking screws did not consistently engage and lock into the threaded holes of the plate as intended. Attempts were made to achieve proper screw engagement using the guide block; however, the screws continued to advance without achieving the expected locking mechanism. This resulted in difficulty obtaining secure screw-to-plate fixation and required removal of the plate. The product and associated instrumentation should be evaluated to determine whether there is a potential issue with the plate threads, locking screw threads, guide block alignment, or compatibility between the components.
Patient problems: Insufficient Information
MAUDE report 50805244 ↗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 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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