Model Number 4515-70-101 |
Device Problems
Malposition of Device (2616); Intermittent Loss of Power (4016)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 06/21/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a total knee arthroplasty surgical procedure, it was observed that while using the robotic-assisted solution satellite station device, it was observed that the saw stuttered and had cut inaccuracies on the anterior chamber.It was reported that the cut was verified with the pointer.It was reported that the clinician did not feel comfortable using cement less components due to inaccurate cuts.It was reported that on one of the cases the sasi connection to the saw was loose.It was reported that the tensioner tends to over tension the flexion gap.It was reported that the device was being used with a robotic assisted base station device.There were no delays in the 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.
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Manufacturer Narrative
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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.D10, concomitant medical devices and therapy dates, base station device, saw interface device, june 21, 2023 d4, h4: the device serial/lot number and date of manufacture are unknown at this time.Udi: (b)(4)unknown.
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Manufacturer Narrative
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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: the actual device was evaluated and there were no defects found with the system and software.A review of the device log files was performed for this event.The investigation of the log files confirmed the reported issue.However, the complaint allegation has been determined to be within operating performance of the device per the provided event description and log file review.However, a root cause could not be established as the investigation found no issues or defects, and the system was operating properly and accurately therefore, the most probable cause cannot be established.
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Manufacturer Narrative
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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.D4, h4: the device serial/lot number and date of manufacture were unknown in the initial report and have been updated accordingly.The device udi has also been updated.Udi: (b)(4).
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Search Alerts/Recalls
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