Model Number 4515-70-101 |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2022 |
Event Type
malfunction
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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.Udi: (b)(4).Concomitant medical devices and therapy dates, base station device, august 9, 2022.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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Event Description
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It was reported during a total knee arthroplasty procedure, it was observed that while using the robotic-assisted solution satellite station device, it was observed that the cuts were accurate but the trial didn't fit well.It was further reported that the anterior cut was checked with the pointer and the screen indicated 0.5 but the trial wasn't fitting flush.The anterior cut appeared to be proud so the surgeon additionally cut freehand and the trial fit better.It was also reported that the order of the cuts was distal cut, proximal tibia, then back to femur.Checked twice with pointer during cuts and it passed both times so it was stated it would indicate there was not array movement and there were no other indications of any array issues.Landmarks seemed to be acquired accurate.Pointer probe showed cut to be accurate so skiving was not believed to have occurred.It was reported that the device was being used with a robotic assisted base station.It was not reported if there was a minimal delay for the additional manual cut.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization reported.
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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.The actual device was evaluated.And there were no observed, defects with the system and software.The device log files were reviewed.And it was observed, that skiving of the saw blade device was viewable in the log files.The reported condition was confirmed.It was determined, that the performance of the sulcus cut was not reviewable in the log files.And could not be determined, from the photos provided.It was determined, that most probable root cause was the handling of the saw handpiece that resulted in skiving or blade deflection on the anterior and distal cuts and whether or not the sulcus cut was performed, prior to placing the trial.It is recommended, that the user follow the guidance on "performing resections", in the instructions for use related to cutting technique to reduce the likelihood of blade deflection.If information is obtained, that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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