The reason for this revision surgery, the agent reported (during case, surgeon took instrument to perform surgery however this broke.Male, 69 ).This event occurred during surgery, near the patient.No response was received by the surgeon.The surgery was completed as intended, with no delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was not able to source a suitable replacement device.Rma examination: the instrument was not returned to djo for further examination, follow up attempts have been issued with no response.If at a later date the instrument is returned, an amendment will be opened to document any new information 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 6 previous complaints but there were no indications that this instrument has a design or material deficiency.The root cause of this complaint is difficult to determine since the device was not returned for evaluation.It is likely attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction, or issue.
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