Model Number 4515-70-105 |
Device Problems
Device Slipped (1584); 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 10/21/2022 |
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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.: as of this date, the device has not been returned for evaluation.Therefore; the reported condition cannot be confirmed and/or duplicated.Concomitant medical devices and therapy dates, robotic assisted saw assembly saw interface, october 21, 2022.Udi: (b)(4).
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Event Description
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This is report 1 of 2 for the same event.It was reported that the robotic assisted saw interface device, one left and one right were loose and not functioning properly.It was reported that the issue was discovered during testing with multiple saw handpiece devices.There was no patient involvement.There were no reports of 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.The actual device was returned for evaluation and found that the reported issue of loose connection was confirmed.A manufacturing record evaluation was performed for the finished device and no non-conformances related to the malfunction were identified.The assignable root cause is determined to be due to design and is being addressed through a capa.
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Search Alerts/Recalls
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