VOLT 02.424.320Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982316448), received between Mar 6, 2026 and Sep 17, 2026 — classified as 7 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.

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 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 ↗
• 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 25350587 ↗
• 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 25350138 ↗
• MalfunctionMar 9, 2026Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: DEPTH GAUGES HAVE BEEN WORN DOWN AND RENDERED UNREADABLE. NEEDS TO BE REPLACED\PLATE BENDER HAS LOOSENED. NO PATIENT HARM AND SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543892 ↗
• MalfunctionMar 9, 2026Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : DEPTH GAUGES HAVE BEEN WORN DOWN AND RENDERED UNREADABLE. NEEDS TO BE REPLACED\PLATE BENDER HAS LOOSENED. NO PATIENT HARM AND SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543874 ↗
• MalfunctionMar 6, 2026Material Twisted/Bent

  IT WAS REPORTED THAT SLOTTED NOSEPIECE FOR CABLE TENSIONER, LABEL SHEET PACK FOR MINI SUPPLEMENTAL SCREW RACK, SUPPLEMENTAL SCREW RACK W/LID FOR 1.5MM/2.0MM/2.4MM SCREWS, 2.4MM VOLT(TM) LOCKING SCREW 20MM T8, LABEL SHEET PACK FOR SMALL SUPPLEMENTAL SCREW RACKS, SUPPLEMENTAL SCREW RACK W/LID FOR 2.7/3.0/3.5/4.0MM SCREWS, GONIOMETER FOR PRE-OPERATIVE PLANNER, ALUMINUM CASE 220MM X 105MM X 40MM, STANDARD ALUMINUM CASE-HIGH RED, AND CUTTER F/TEN WERE REPORTED AS WORN DOWN AND RENDERED UNUSABLE DUE TO ROUTINE WEAR-AND-TEAR. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY WAS NOTED. THE AFFECTED DEVICES WERE REQUESTED TO BE REPLACED AND ARE AVAILABLE FOR RETURN. THE COMPLAINT INVOLVES MULTIPLE REUSABLE INSTRUMENTS, AND THE ISSUE WAS NOT FOUND DURING USE BUT IS CONSIDERED END-OF-LIFE RELATED AS DEFINED IN THE INSTRUCTIONS FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532256 ↗