Catalog Number 451570106 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
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 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 2 of 4 for (b)(4).
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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.H4: the device manufacture date is unknown at this time.Udi: (b)(4).
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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.H11 additional narrative: the actual device was not returned for evaluation, however photos and videos were provided for review.Upon review, it was found that the interaction between the sasi clamping mechanisms and saw handpiece while assembled had slight mechanical play/looseness in the direction parallel with the saw blade.However, due to the angle in which the videos were taken, it is not possible to identify the lot number of the the device and therefore, cannot be associated with one particular report.Investigations will be completed on manufacturer report numbers 1818910-2024-06573 and 1818910-2024-06587.The overall complaint was confirmed as the observed condition of the device would be expected to contribute to the complained device issue.The issue related to the looseness is being addressed through a capa.The assignable root cause was due to design.
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Search Alerts/Recalls
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