It was reported that during a total knee arthroplasty surgical procedure, it was observed that four (x4) the robotic assisted saw interface devices (sasi) two right and two left were being used when it was found that twice, the bottom clamp opened during a case and caused a terminal error.She said all 4 sasis have this issue of being loose so they have using coban to close the clamp.The connection between the sasi and the saw is also loose on all 4 sasis causing saw cut out.It was reported that there was an unspecified delay in the procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.This is report 3 of 4 for (b)(4).
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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 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.Udi: (b)(4).
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