Catalog Number 61921010 |
Device Problems
Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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Shipped to facility and the outer box was damaged.Inside of box was damaged also.As per initial reporter on (b)(6) 2016: the ampoules were smashed, you could hear broken glass sliding around.
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Manufacturer Narrative
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An event regarding packaging damage involving simplex bone cement was reported.The event was confirmed based on the photograph provided.Method & results: device evaluation and results: no product was returned for evaluation however a photograph was provided which shows extensive damage to the sides of the shipper box and the 10-pack of bone cement within.The shipper box appears to have been crushed in transit.Medical records received and evaluation: not performed as there was no patient involvement.Device history review: review of the batch manufacturing record indicates that this batch was manufactured and shipped to stock with no reported discrepancies.Complaint history review: review determined that there were no other similar reported events for the lot.Conclusions: no product was returned for evaluation however a photograph was provided which shows extensive damage to the sides of the shipper box and the 10-pack of bone cement within.The shipper box appears to have been crushed in transit.A capa trend analysis was conducted for the reported failure mode and concluded simplex packaging damage may result from other factors not necessarily related to the product.No further investigation is possible at this time as no product and insufficient information was received by stryker orthopaedics.If additional information becomes available this investigation will be reopened.
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Event Description
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Shipped to facility and the outer box was damaged.Inside of box was damaged also.As per initial reporter on 8/25/2016: the ampoules were smashed, you could hear broken glass sliding around.
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Search Alerts/Recalls
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