This is report 1 of 2 for the same event.It was reported that during a total knee arthroplasty surgical procedure, it was observed that while using the robotic assisted saw interface right (sasi) and the robotic assisted saw handpiece device it was reported that the housing of the saw was loose and there was a lot of vibration.It was reported that as a result, the cuts were over resected by 2mm.It was reported that this occurred on the last 3-4 knees.It was reported that they do not believe it is the same saw or sasi in each event as they have multiple sets.It was reported that the device was also being used with a robotic assisted satellite station device and a base station device.It was reported that there were no delays in the surgical procedure.There was patient involvement.There were no 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.
|
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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.D10, concomitant medical devices and therapy dates, base station device, satellite station device and saw interface device, september 12, 2023.D4, h4: the device serial/lot number and date of manufacture are unknown at this time.Udi: (b)(4).
|