This mdr was identified as part of complaint file remediation project.The doctor implanted an 18x18mm motoclip implant and a motoband 4 hole plate on (b)(6) 2017.During routine follow up visits, the doctor noticed that the fusion site was experiencing a delayed union.A bone stimulator was used to promote fusion.During additional follow up visits, the doctor noticed that the fusion site appeared to have experienced proper fusion.The doctor instructed the patient to start weight bearing.Another follow up visit revealed that one of the plate screws had backed out of the plate and the motoclip implant had mechanically fractured in one of the legs.The broken hardware was symptomatic and causing irritation for the patient.The doctor performed a revision surgery in order to remove the broken hardware.Due to the sufficient fusion present at the site, the doctor did not implant additional hardware once the initial hardware was explanted.The size and lot of the screw that backed out are unknown.No defects were found with the crossroads motoclip or motoband implants that were used.The device failure category is currently unknown and potentially related to weight-bearing prior to fusion.The nitinol clip listed previously was used in conjunction with the implants listed below as a total construct for bone fragment osteotomy fixation and joint arthrodesis: motoband 4-hole straight plate part number 1500-0005 lot number 101692 screw part number and lot number unknown.
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