Catalog Number 451570105 |
Device Problems
Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2023 |
Event Type
malfunction
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Event Description
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It was reported from australia that the robotic assisted saw interface device had an unspecified malfunction.During an in-house engineering evaluation, it was determined that the device had significant mechanical play/looseness at saw interface in the direction parallel with the saw blade plane.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any 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: the actual device was returned for evaluation.During evaluation it was found that there was significant mechanical play/ looseness at saw interface in the direction parallel with the saw blade plane.Visual examination found no signs of damage or improper usage.The overall appearance of the device shows signs of normal and repetitive usage.The issue related to the play between the saw handpiece and the saw interface is related to a capa.The assignable root cause is due to design.(b)(4).
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Search Alerts/Recalls
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