Catalog Number 61921010 |
Device Problems
Break (1069); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 10/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Per sales rep, the hospital ordered a box of bone cement speed set.There was a busted vial.
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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 photographs provided.Method & results: -device evaluation and results: no product was returned for evaluation however photographs were provided which shows discoloration to the shipper box and 10 pack carton.There are also photographs showing damage to the single unit pack as well as a deformed blister with the tyvek lid removed and a broken vile.When the ampoule was broken the monomer leaked out causing the damage to the packaging and to both the tyvek seal and the blister.This damage is consistent with excessive inappropriate handling.-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 photographs were provided which shows discoloration to the shipper box and 10 pack carton.There are also photographs showing damage to the single unit pack as well as a deformed blister with the tyvek lid removed and a broken vile.When the ampoule was broken the monomer leaked out causing the damage to the packaging and to both the tyvek seal and the blister.This damage is consistent with excessive inappropriate handling.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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Per sales rep, the hospital ordered a box of bone cement speed set.There was a busted vial.
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Search Alerts/Recalls
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