VOLT 02.424.318Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982316400), received between Apr 16, 2026 and Sep 29, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 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

  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 ↗
• 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 25069111 ↗
• MalfunctionApr 16, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEVICES WERE UNABLE TO BE STERILIZED OR ASSEMBLED; SOME WERE CHIPPING AND CRACKING. DEVICES WERE NOT USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903679 ↗