SAFE GAIT ACTIVE 360 DYNAMIC MOBILITY TRAINER

Additional Manufacturer Narrative

THE DEVICE IN THIS LOT WAS 1 OF 4 MANUFACTURED BY A SUPPLIER NO LONGER USED BY DIH. THE ASSEMBLY OF THE SPREADER BAR HAS MOVED TO OUR OWN MANUFACTURING FACILITY WHERE QA PROCEDURES ARE IN PLACE TO DETECT DEFECTIVE SELF-LOCKING NUTS. SINCE THE SUSPECT LOT OF DEVICES HAVE BEEN INSPECTED, WE HAVE DETERMINED THAT IT IS IMPROBABLE FOR THIS EVENT TO REOCCUR.

Description of Event or Problem

DIH TECHNOLOGIES, INC. RECEIVED A REPORT STATING THE CENTER BOLT ON YOKE OF THE SPREADER BAR BECAME DETACHED DURING A PATIENT SESSION. THE CAREGIVER WAS ABLE TO STABILIZE THE PATIENT DURING THE EVENT. NO ADVERSE EVENT OCCURRED. THE SPREADER BAR WAS REPLACED ON THIS DEVICE. THE SPREADER BAR ASSEMBLY WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PRIMARY ROOT CAUSE WAS DETERMINED THAT THE SELF-LOCKING NUT DESIGNED TO PREVENT THE SPREADER BAR FROM DETACHING WAS DEFECTIVE. THE DEFECTIVE NUT WAS FOUND TO HAVE GAPS THAT WERE OUT OF SPECIFICATION. THESE GAPS DID NOT ALLOW THE PROPER ENGAGEMENT WITH THE CENTER BOLT. IN NORMAL OPERATION, THE SPREADER BAR CAN SPIN 360 DEGREES ON A BEARING THAT IS INSTALLED ABOVE THE SELF-LOCKING NUT. SINCE THE SELF-LOCKING NUT WAS NOT ENGAGING WITH THE BOLT SUFFICIENTLY, EXPECTED FORCES APPLIED FROM THE PATIENT'S WEIGHT ALLOWED THE NUT TO BACK-OFF AS THE SPREADER BAR ROTATED. SPREADER BAR ASSEMBLIES FROM THIS LOT WERE INSPECTED FOR DEFECTIVE NUTS AND NO ADDITIONAL DEFECTS WERE FOUND. THE ANNUAL MAINTENANCE RECORDS OF ALL OTHER FIELD UNITS DO NOT SHOW ANY DEFECTIVE NUTS.