It was reported that there was a hole in the hose of the motor device.During service and evaluation, it was discovered that the motor device ran in a locked position- power broken, could not secure/lock cutter and had component damage.It was further determined that the device failed pretest for visual assessment, cutter lock assessment and safety assessment.The event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.The exact date of the event was unknown.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.Additional narrative: device evaluation: the actual device was returned for evaluation.During repair an evaluation was performed and it was determined that the reported condition that the hose of the motor device had a hole in it was not confirmed.Therefore, an assignable root cause for the reported condition of cord damage was not determined.However, during evaluation, it was determined that the device ran in a locked position-power broken.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).
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