VOLT¿ WRIST TREATMENT SYSTEM

Additional Manufacturer Narrative

THE EVENT WAS EVALUATED AND INVESTIGATED AIDED BY INFORMATION PROVIDED BY THE COMPLAINANT. THE DEVICE REMAINS IMPLANTED; THEREFORE, A DEVICE EVALUATION COULD NOT BE CONDUCTED. A REVIEW FOR LOT-RELATED NONCONFORMITIES COULD NOT BE PERFORMED AS NOT LOT-IDENTIFYING INFORMATION WAS MADE AVAILABLE. A HISTORICAL TREND ANALYSIS IDENTIFIED NO TRENDS OR CAPAS RELATED TO THE NATURE OF THIS EVENT. ALTHOUGH DEVIATION FROM THE SYSTEM'S RELEASED SURGICAL TECHNIQUE WAS NOTED BY NOT USING A DRILL GUIDE FOR HOLE PREPARATION, THE ROOT CAUSE CANNOT BE ESTABLISHED WITH THE CURRENT INFORMATION OR THE EVALUATION OF THE IMPACTED DEVICE.

Description of Event or Problem

INFORMATION PROVIDED BY THE COMPLAINANT: IT WAS REPORTED THAT ON (B)(6) 2025, DISTAL STYLOID SCREW IS BACKING OUT OF A VOLT DISTAL RADIUS PLATE. PLATE NEEDS TO BE REMOVED AT A LATER DATE. A NEW DRILL HOLE NEEDED TO BE MADE USING A FREE HAND TECHNIQUE AND THE SURGEON ALSO HAD PROBLEMS ENGAGING THE FAR CORTEX OF THE SCREW. THE STYLOID SCREW WAS INSERTED BY HAND AND NO DRILL GUIDE WAS USED THE SECOND TIME AS THE SURGEON REDIRECTED THE DRILL WITHOUT A GUIDE. THE SCREW DID NOT HAVE GOOD CONNECTION TO THE PLATE AND THE EVENT OCCURRED INTRA-OPERATIVELY. SURGERY WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY. CASE COMPLETED. PLATE IS STILL IN THE PATIENT AND WILL BE REMOVED AFTER THE PATIENT HEALS. THE PATIENT IS HEALING AND OK.