This is report 2 of 2 for the same event.It was reported from (b)(6) that even when the battery oscillator device was well dried, water remained in the device and the device leaked water.It was reported that this event occurred with two battery reciprocator devices.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
H10: depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.The battery oscillator device was evaluated and the reported condition that when the battery oscillator device was well dried, water remained in the device and the device leaked water was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the trigger of the device was not moving smoothly.The assignable root cause of this condition was determined to be traced to component failure due to wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|