Catalog Number 5532-G-511 |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/28/2015 |
Event Type
malfunction
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Event Description
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Surgeon was doing a total knee on patient and when surgeon asked for the insert to be opened, immediately upon opening the inner packaging the insert was noticed to be a different type and size than what was listed on the outer box.Box stated part as p# 5532-g-511 lot ld807y and implant inside box was p#5537-g-319 lot tt6jt2.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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Device history review: review of the device history records indicate devices were manufactured and accepted into final stock complaint history review: there has been (b)(4) other event for this lot.Nc pr was previously raised for the same product and issue.A full complaint investigation was conducted and documented under pr and determined the product mix occurred due to a router swap.Nc was raised to investigate and address the confirmed product mix and router swap.
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Event Description
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Surgeon was doing a total knee on patient and when surgeon asked for the insert to be opened, immediately upon opening the inner packaging the insert was noticed to be a different type and size than what was listed on the outer box.Box stated part as p# 5532-g-511 lot ld807y and implant inside box was p#5537-g-319 lot tt6jt2.
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Search Alerts/Recalls
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