DEPUY IRELAND VELYS SAW HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Model Number 4515-70-102 |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2022 |
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.Investigation summary: upon evaluation of the event it was determined that the failure described by the customer was confirmed.Review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The issue related to the loose saw connection has been escalated to a capa.The assignable root cause could not be determined.
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Event Description
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This report 2 of 2 for the same event.It was reported that during a total knee arthroplasty surgical procedure, it was observed that the robotic assisted saw interface device left was too loose when connected to the robotic assisted saw handpiece device.It was reported that they were unable to tighten or adjust to get rid of the movement.Additionally, it was reported that a robotic assisted saw handpiece device was cutting in and out.There were no delays in the procedure.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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