It was reported by the customer in (b)(6) that during a knee procedure on (b)(6) 2022, it was observed that the micro tornado hp w handcontrol device was shaking violently.It was further reported that after operation, they changed to a new electrode to test but an error message "output short" was displayed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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Udi: (b)(4).The serial number was unknown.The serial number was unknown; therefore, the manufacturing site name, and device manufacture date were unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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