The reason for this instrument failure was reported as the early mixture of the cement.The possible time in service for the main contributor of the complaint is unknown form the manufacture date.The healthcare professional indicated this event occurred during surgery near the patient.There was another suitable device available for use.The incident did cause a 20 minute delay in surgery, however, surgery was completed as intended.There was no risk to the patient and the instrument was inspected prior to surgery and was found to be acceptable.The devices were disposed of at hospital and not made available to djo surgical for examination.The revision level or lot number were not reported, therefore this instrument could not be linked to a specific device history record (dhr) or the actual date of manufacture could not be determined with confidence.Complaint database review showed no previous complaints that allege this same issue.The root cause of this complaint is likely due to the early mixture of the cement.This is an event associated with surgical error, not an event associated with product failure, malfunction, or issue.There are no indications that these instruments have a design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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