It was reported by the biomedical technical from france that during an unspecified surgical procedure, it was discovered that the engine of the motor device was very hot.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was 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 report will be submitted accordingly.
|
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained, that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed.And it was determined, that the reported condition of the engine of the motor device getting very hot was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined, that the device had a component damage and displayed an e6 error code, indicating handpiece overheat warning.It was further determined, that the device failed pretest for motor thermistor assessment.The assignable root cause was determined, to be due to component failure from wear.
|