Corrected data: see d.6a & d.6b.Manufacturer narrative: the reason for this instrument failure was reported as surgeon was unable to dislocate hip once trials were in and hip was reduced.The healthcare professional indicated this event occurred during surgery, near the patient.With this incident a delay of 10 minutes prolonged surgery time.The surgery was completed as intended and 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 able to source a suitable replacement device.The components of this surgery are not being returned and were either lost or discarded at the hospital.The revision level or lot number were not reported; therefore, this instrument could not be linked to a specific device history records (dhr) or the actual date of manufacturer could not be determined with confidence.Complaint database review shows zero prior complaints filed against the instruments' item number or lot number.No prior complaints report past instances of these instruments being affected by this failure.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.There are no indications that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was not returned to djo, instrument was not returned per the product feedback form.
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