This is report 2 of 2 of the same event: it was reported from japan that the motor device and compact speed reducer device were generating heat while being used together.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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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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.H10 additional narrative: d10: concomitant med products and therapy dates: compact speed reducer device, (b)(3) 2023.E1: the reporter¿s phone number was not provided.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the device had cord damage, cosmetic damage, worn bearing, made an excessive noise and generated heat.It was further determined that the device failed pretest for visual assessments, noise assessment, and handpiece temperature assessment.Therefore, the reported condition of the device generating heat was confirmed.The assignable root cause was determined to be due to component failure from wear.Udi:(b)(4).
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