Catalog Number 5521-B-200 |
Device Problems
Device Disinfection Or Sterilization Issue (2909); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/20/2015 |
Event Type
malfunction
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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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Event Description
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The box for the base plate was removed and as the nurse began to open up the first package to drop the implant in the sterile field, the innermost package was stuck to the outer piece and partially pulled back.We decided not to risk any sterility issues and did not place the implant on the sterile field and used a different base plate.The implant was never completely opened and never placed on the sterile field.
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Manufacturer Narrative
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An event regarding a packaging issue involving a triathlon baseplate was reported.The event was confirmed.Method & results: -device evaluation and results: the inner blister lid had delaminated.It is possible the lid stuck to the outer blister lid and delaminated when the outer lid was peeled back.It is noted that both blisters showed evidence of complete seal transfer.There is no indication that the sterility of the device was compromised.-medical records received and evaluation: not performed as the event is not related to patient factors.-device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the inner blister lid had delaminated.It is possible the lid stuck to the outer blister lid and delaminated when the outer lid was peeled back.The root cause was determined to be a known packaging issue.Packaging innovations is aware of this, and has issued a memo.
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Event Description
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The box for the base plate was removed and as the nurse began to open up the first package to drop the implant in the sterile field, the innermost package was stuck to the outer piece and partially pulled back.We decided not to risk any sterility issues and did not place the implant on the sterile field and used a different base plate.The implant was never completely opened and never placed on the sterile field.
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Search Alerts/Recalls
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