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.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).
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It was reported from (b)(6) that the engine of the battery handpiece device was overheating and there was a poor contact.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no 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 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: the actual device was returned for evaluation.The handpiece device was evaluated and the reported condition that the engine was overheating was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device would not run, would not hold/secure a battery, failed leak tightness test, had illegible etching, and the housing was deformed/bent.It was further determined that the device failed pretest for check function of the device, check wear on housing, check fitting of the lid, check falling out protection (steel ring), check the roundness of the housing, leakage test, and marking and labeling.Therefore, the reported condition of a poor contact was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is user error/misuse/abuse.
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