Catalog Number 0580-1-440 |
Device Problems
Product Quality Problem (1506); Out-Of-Box Failure (2311); Device Operates Differently Than Expected (2913); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/06/2015 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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Hospital contacted me to say when they opened this stem, the spigot protector was damaged and they were not able to load the stem onto the stem introducer.Another stem was opened and used.
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Manufacturer Narrative
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An event regarding a damaged spigot protector involving an exeter stem was reported.The event was confirmed.Method & results: -device evaluation and results: evaluation by the supplier confirmed that one lug of the spigot is bent.-medical records received and evaluation: not performed as medical records were not received for evaluation.-device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: a review of the complaint history database shows that there have been no similar events for the reported lot.Conclusions: the investigation concluded that the root cause of this event was due to a manufacturing issue with the spigot supplier.A review by supplier quality confirms the event is within the scope of capa.
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Event Description
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Hospital contacted me to say when they opened this stem, the spigot protector was damaged and they were not able to load the stem onto the stem introducer.Another stem was opened and used.
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Search Alerts/Recalls
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