This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined that the device was overheating from the motor during use.The motor was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.
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It was reported that the handle heated up after connecting the power supply and did not work before surgery.There was no evidence of burning, charring, smoke, or spark.No patients were included.Evaluation of this device later revealed that the device's motor speed was below spec.No adverse events were reported as a result of this malfunction.
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