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.E1: the reporter¿s phone number: (b)(6).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 device displaying an e6 error code indicating handpiece overheat warning, was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device ran in locked position.It was determined that the device failed pretest for safety assessment.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
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It was reported from china that during an unspecified surgical procedure, it was discovered that the motor device displayed an e6 error code indicating handpiece overheat warning.It was not reported if there were any delays to the surgical procedure.It was reported that a spare device was used to complete the surgery.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.
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