It was reported that during service and repair pre-testing, it was discovered that the impactor device had medical debris and could not remove cup.It was further reported that the device had corrosion/rusting/pitting.The event was not related to surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.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 conditions of unable to disassemble, corrosion/rusting/pitting and medical debris identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.Udi: (b)(4).
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