It was reported that during cleaning, it was observed that the impactor device was sputtering and would not fire.It was reported that multiple battery devices were tried with the same result.During in-house engineering evaluation, it was observed that the device was visually and functionally assessed, and the trigger was observed to be difficult to press/depress, consistent with lack of lubricant ¿ improper maintenance.It was further determined that the impactor did not produce impacts for reasons that remain unidentified.It was further determined that the device failed pretest for impactor operation assessment.This event did not occur during surgery.There was no patient involvement.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: d10: concomitant med products and therapy dates: battery devices, (b)(6) 2023 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 having an intermittent operation was not confirmed.Therefore, an assignable root cause was not determined.However, the sticky trigger, identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.The device not running was due to component failure from normal wear.
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