Catalog Number 0580-1-443 |
Device Problems
Product Quality Problem (1506); Out-Of-Box Failure (2311); Device Issue (2379); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 03/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.
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Event Description
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The customer reported that the spigot protector on the exeter 44 no 3 is too thick to fit the instrumentation.The device was inserted by hand.No time delay, but surgical flow disrupted and an alteration to surgical technique due to being unable to attach the implant to the implant introducer.
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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.The returned spigot show 2 bent lugs: lugs are still parallel but they are not perpendicular to the body of the spigot.The lugs are bent outwards the investigation concluded that the root cause of this event was due to a manufacturing issue with the spigot supplier to lisi.The supplier investigation determined the device escaped inspection.
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Event Description
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The customer reported that the spigot protector on the exeter 44 no 3 is too thick to fit the instrumentation.The device was inserted by hand.No time delay, but surgical flow disrupted and an alteration to surgical technique due to being unable to attach the implant to the implant introducer.
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Search Alerts/Recalls
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