Model Number 4515-70-105 |
Device Problem
Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2022 |
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 the robotic assisted saw interface left (sasi) locking clamp where it attaches to the top of the robot became disconnected.It was reported that this issue was noticed when the saw console device had an error.It was reported that this occurred prior to the posterior chamfer cut.It was further reported that the clamp was re-attached to the sasi and a full shutdown and re-registered the patient in order to successfully finish the tibia cuts robotically without any issues.It was reported that there was a few minute delay.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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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.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Device manufacture date is unknown.The device serial or lot number is unknown 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: investigation summary: the actual device was not returned for evaluation and therefore, the reported issue could not be confirmed nor duplicated.The assignable root cause could not be determined.Depuy considers the investigation closed.Should additional information or the device be received in the future, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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