Catalog Number 451570106 |
Device Problems
Device Slipped (1584); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2024 |
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 the four (x4) robotic assisted saw interfaces two right and two left (sasi) devices caused the saw to stop functioning.They also reported that the clamp is getting loose on the saw side so it's causing the clamp to come loose easily.Additionally it was reported that two of their saw handpieces have connectors that are bent causing an unstable connection to the sasis.It was not reported if there were any delays in the surgical procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.This is report 1 of 4 for the same event.
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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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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.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, saw handpiece devices, (b)(6) 2024.Udi: (b)(4).The device manufacture date is unknown at this time.
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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 product was not returned to depuy synthes, however photos were provided for review.Review of the photographic evidence revealed the lateral side of a velys saw interface right only.Only the product code and lot number was retrieved, no defects that could have contributed to the reported event were observed.Additionally, functionality issues cannot be assessed through a photo investigation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photographs provided contained insufficient evidence of the reported event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
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Search Alerts/Recalls
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